Yoga Therapy as an Intervention to Improve Patient-Reported Outcomes Among Adults After Treatment for Cancer: Preliminary Findings From a Trial Using Single-Subject Experimental Design.

BACKGROUND: Cancer is a chronic condition associated with a substantial symptom burden, which can impair recovery after treatment. Investigating interventions with potential to improve self-reported disease and/or treatment effects-known as patient-reported outcomes (PROs)-is paramount to inform cancer care. The objective of this study was to evaluate the effects of a yoga therapy (YT) intervention on key PROs (ie, cancer-related fatigue, anxiety, cognitive function, depression, stress, quality of life [QoL]) among adults after treatment for cancer. METHODS: Data from 20 adults (Mage = 55.74 years, 85% female; Mtime since diagnosis = 2.83 years) who had completed treatment for cancer were analyzed for this study. In this single-subject exploratory experimental study, the YT intervention comprised a 1:1 YT session (ie, 1 participant with 1 yoga therapist) followed by 6 weekly small (ie, 2-3 participants) group YT sessions. Group sessions were facilitated by the same yoga therapist who delivered participants' 1:1 session to ensure an in-depth personalized approach. PROs were assessed before (ie, pre-intervention) and after the 1:1 YT session (ie, during the intervention), as well as after the last group YT session (ie, post-intervention). Hierarchical linear modeling was used to analyze the data. RESULTS: Participants showed improvements in cancer-related fatigue, state anxiety, trait anxiety, perceived cognitive impairments, impacts of perceived cognitive impairments on QoL, and 1 dimension of QoL (ie, functional wellbeing) over time. Notably, cancer-related fatigue and state anxiety increased immediately after the 1:1 session, but showed greater improvements over time afterward (ie, during the intervention phase). No changes were observed for the remaining PROs. CONCLUSION: Although results require confirmation in future trials, this study highlights the importance of continuing to investigate YT as an intervention to enhance important PROs (ie, cancer-related fatigue and state anxiety) after treatment for cancer. More research is needed to identify additional beneficial effects and factors that influence participants' responses to 1:1 and group YT (ie, moderators and mediators). REGISTRATION NUMBER: ISRCTN64763228. DATE OF REGISTRATION: December 12, 2021. This trial was registered retrospectively. URL OF TRIAL REGISTRY RECORD: https://www.isrctn.com/ISRCTN64763228. PUBLISHED PROTOCOL: Brunet, J., Wurz, A., Hussien, J., Pitman, A., Conte, E., Ennis, J. K., . . . & Seely, D. (2022). Exploring the Effects of Yoga Therapy on Heart Rate Variability and Patient-Reported Outcomes After Cancer Treatment: A Study Protocol. Integrative Cancer Therapies, 21, 15347354221075576.

Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: a double-blind randomised controlled trial.

BACKGROUND: COVID-19 has caused morbidity, hospitalisation and mortality worldwide. Despite effective vaccines, there is still a need for effective treatments, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. We sought to evaluate whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc could improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19. METHODS: Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 µg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality. RESULTS: 90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes. INTERPRETATION: In this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility. TRIAL REGISTRATION NUMBER: NCT04780061.

Mistletoe Extracts during the Oncological Perioperative Period: A Systematic Review and Meta-Analysis of Human Randomized Controlled Trials.

BACKGROUND: We aim to evaluate the safety and efficacy of mistletoe extract (ME) use during the oncological perioperative period. METHODS: Details registered a priori on PROSPERO (CRD42018086168). RESULTS: Seven RCTs (comprising 663 participants in nine reports) and three nonrandomized studies were included. In five RCTs, ME was evaluated as adjunctive care and the control group had no additional intervention, whereas in two RCTs, ME was compared head-to-head against common cancer treatments (i.e., etoposide or bacillus Calmette-Guérin) with the intervention groups not receiving standard care. Meta-analyses found no evidence for a difference between ME and no added therapy for mortality and recurrence (RR, 95% CI: 1.00, 0.79-1.27; and 1.03, 0.79-1.33, respectively). Two RCTs reported beneficial effects of ME on immune cells, specifically natural killer cells, in colorectal cancer, and one RCT reported quality of life improvement. Two RCTs reported ME discontinuations due to adverse events and grade 3/4 toxicities. Nevertheless, no safety signals were detected from these 10 studies. Quality appraisal revealed a substantial risk of bias. CONCLUSIONS: Preliminary data are encouraging for mistletoe extracts, particularly in the context of colorectal cancer. However, the evidence is limited by the number of studies, an evaluation of different outcomes, and methodological limitations. Further high-quality research is warranted.

Integrative Oncology Care of Symptoms of Anxiety and Depression in Adults With Cancer: Society for Integrative Oncology-ASCO Guideline.

PURPOSE: To provide evidence-based recommendations to health care providers on integrative approaches to managing anxiety and depression symptoms in adults living with cancer. METHODS: The Society for Integrative Oncology and ASCO convened an expert panel of integrative oncology, medical oncology, radiation oncology, surgical oncology, palliative oncology, social sciences, mind-body medicine, nursing, methodology, and patient advocacy representatives. The literature search included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2023. Outcomes of interest included anxiety or depression symptoms as measured by validated psychometric tools, and adverse events. Expert panel members used this evidence and informal consensus with the Guidelines into Decision Support methodology to develop evidence-based guideline recommendations. RESULTS: The literature search identified 110 relevant studies (30 systematic reviews and 80 randomized controlled trials) to inform the evidence base for this guideline. RECOMMENDATIONS: Recommendations were made for mindfulness-based interventions (MBIs), yoga, relaxation, music therapy, reflexology, and aromatherapy (using inhalation) for treating symptoms of anxiety during active treatment; and MBIs, yoga, acupuncture, tai chi and/or qigong, and reflexology for treating anxiety symptoms after cancer treatment. For depression symptoms, MBIs, yoga, music therapy, relaxation, and reflexology were recommended during treatment, and MBIs, yoga, and tai chi and/or qigong were recommended post-treatment. DISCUSSION: Issues of patient-health care provider communication, health disparities, comorbid medical conditions, cost implications, guideline implementation, provider training and credentialing, and quality assurance of natural health products are discussed. While several approaches such as MBIs and yoga appear effective, limitations of the evidence base including assessment of risk of bias, nonstandardization of therapies, lack of diversity in study samples, and lack of active control conditions as well as future research directions are discussed.Additional information is available at www.asco.org/survivorship-guidelines.

Complete Remission of BCG-Refractory High-grade Bladder CIS with Pharmacologic Ascorbate and Mistletoe.

Context: Bladder cancer is the fourth-most-common cancer in males in the U.S., who develop about 90% of the high-grade, carcinoma in situ (CIS) of non-muscle involved disease (NMIBC). Smoking and occupational carcinogens are well-known causes. For females without known risk factors, bladder cancer can be regarded as a sentinel environmental cancer. It's also one of the costliest to treat due to its high rate of recurrence. No treatment innovations have occurred in nearly two decades; intravesical instillation of Bacillus Calmette-Guerin (BCG), an agent in short supply globally, or Mitomycin-C (MIT-C) is effective in about 60% of cases. Cases refractory to BCG and MIT-C often undergo cystectomy, a procedure with numerous impacts on life styles and potential complications. The recent completion of a small Phase I trial of mistletoe in cancer patients that have exhausted known treatments at Johns Hopkins provides corroboration of its safety, with 25 % showing no disease progression. Objective: The study examined the benefits of pharmacologic ascorbate (PA) and mistletoe for a nonsmoking female patient with an environmental history of NMIBC refractory to BCG, in a non-smoking female with exposures in childhood and early adult life to several known carcinogens, including ultrafine particulate air pollution, benzene, toluene, and other organic solvents, aromatic amines and engine exhausts, and possibly arsenic in water. Design: The research team performed an integrative oncology case study on pharmacologic ascorbate (PA) and mistletoe, both agents shown to activate NK cells, enhance growth and maturation of T-cells, and induce dose-dependent pro-apoptotic cell death, suggesting shared and potentially synergistic mechanisms. Setting: The study began at the University of Ottawa Medical Center in Canada with treatment continuing over six years at St. Johns Hospital Center in Jackson, Wyoming, and George Washington University Medical Center for Integrative Medicine, with surgical, cytological, and pathological evaluations at University of California San Francisco Medical Center. Participant: The patient in the case study was a 76-year-old, well-nourished, athletic, nonsmoking female with high-grade CIS of the bladder. Her cancer was considered to be a sentinel environmental cancer. Intervention: Intravenous pharmacologic ascorbate (PA) and subcutaneous mistletoe (three times weekly) and intravenous and intravesical mistletoe (once weekly) were employed for an 8-week induction treatment, using a dose-escalation protocol as detailed below. Maintenance therapy was carried out with the same protocol for three weeks every three months for two years. Results: The patient has experienced a cancer-free outcome following 78 months of treatments that incorporated intravesical, intravenous, and subcutaneous mistletoe; intravenous PA; a program of selected nutraceuticals; exercise; and other supplementary treatments. Conclusions: This study is the first reported instance of combined treatments to achieve complete remission for high-grade NMIBC refractory to BCG and MIT-C, using intravesical, subcutaneous, and intravenous mistletoe and intravenous PA. It includes pharmacological information on possible mechanisms. In light of the global shortage of BCG, the high proportion of cases refractory to BCG and MIT-C, the unproven use of costly off-label pharmaceuticals, such as gemcitabine, and the relative cost-effectiveness of mistletoe and PA, clinicians should give serious consideration to employing these combined functional medicine treatments for BCG- and MIT-C-refractory NMIBC. Further research is needed with additional patients that can advance our understanding, including standardization of methods for systematically evaluating combined therapies-blinded and non-blinded, nomenclature regarding mistletoe preparation, doses, concentrations, regimes of administration, lengths of treatment, targeted cancer types, and other aspects.

A survey of multidisciplinary healthcare providers utilizing the KNOWintegrativeoncology.org educational platform.

BACKGROUND: Although the vast majority of cancer patients use natural health products (NHPs), 59% of oncology healthcare providers (HCP) report not receiving any education on NHPs. KNOWintegrativeoncology.org (KNOW) is a web-based educational platform that provides up-to-date evidence on NHPs used in cancer care with a user-friendly interface. KNOW is a database of human studies systematically gathered from MEDLINE and EMBASE. We surveyed HCPs before and after accessing KNOW to identify their information needs regarding NHPs in cancer care, their preferred way to receive information, barriers they face accessing NHP information, and to obtain feedback on the website. METHODS: Recruitment was done through Beaumont Health Systems, the Society for Integrative Oncology, and the Andrew Weil Centre for Integrative Medicine, University of Arizona. HCPs who consented completed an initial survey and then a follow-up survey after being given access to KNOW for 4-6 weeks. Participants were required to access KNOW at least three times before completion of the follow-up survey. RESULTS: A total of 65 participants completed the initial survey, with 60% (n = 39) from the conventional medical community, 33% (n = 21) from the integrative medicine community, and 7% (n = 5) from the research community. The majority of participants (82%; n = 53) preferred educational websites to email updates, podcasts/webinars, in-house experts, PubMed searches and smartphone apps. The most common barriers identified to accessing information on NHPs were time, accessibility at point-of-care, and credibility of sources. A high number of participants were lost to follow up, with 18 participants demographically representative of the initial sample of 65 completing the follow-up survey. Half (n = 9) of participants stated accessing the KNOW website changed their clinical practice. Close to 90% (n = 16) reported they would recommend KNOW to a colleague. CONCLUSION: Oncology HCPs reported preferring to use, and already relying on, numerous web-based educational platforms to gather information on NHPs, with time, accessibility, and credibility being common barriers to obtaining information. Our study findings highlight the promise of the KNOW web-based educational platform in reducing barriers to accessing up-to-date information on NHPs in busy cancer care settings.

Exploring the Effects of Yoga Therapy on Heart Rate Variability and Patient-Reported Outcomes After Cancer Treatment: A Study Protocol.

BACKGROUND: Following cancer treatment, adults commonly report worsened patient-reported outcomes (PROs) such as anxiety, stress, depression, persistent and upsetting cognitive complaints, unrelenting fatigue, and reduced quality of life. Poorer PROs are associated with disrupted autonomic nervous system functioning as measured by heart rate variability (HRV), both of which have been associated with greater morbidity and mortality. Interventions to improve HRV and PROs among adults following cancer treatment are needed. Yoga therapy holds promise as an intervention to improve HRV and PROs. Therefore, we conducted a single-subject exploratory experimental study to investigate the effects of yoga therapy on HRV and specific PROs (ie, cancer-related fatigue, anxiety, cognitive function, depression, stress, quality of life) in adults treated for cancer. To reduce publication bias, improve reproducibility, and serve as a reference for forthcoming reporting of study results, we present the study protocol for this study herein. METHODS: Participants were adults who completed cancer treatment that were recruited from the Ottawa Integrative Cancer Centre. Consenting and eligible participants received one 1:1 yoga therapy session (ie, 1 participant, 1 Yoga Therapist) and 6 weekly group-based yoga therapy sessions (ie, 2-3 participants, 1 Yoga Therapist). Participants completed assessments 7 times: 3 times prior to the program (ie, -6 weeks, -3 weeks, immediately prior to the 1:1 yoga therapy session), immediately following the 1:1 yoga therapy session, prior to the first group-based yoga therapy session, after the last group-based yoga therapy session, and at a 6-week follow-up. Hierarchical linear modeling will be used to test the average effects of the yoga therapy program across participants. DISCUSSION: This study will explore several novel hypotheses, including whether yoga therapy can improve HRV and/or specific PROs among adults treated for cancer acutely (ie, during a 1:1 yoga therapy session) and/or through repeated exposure (ie, after completing 6 weeks of group-based yoga therapy). Although the findings will require confirmation or refutation in future trials, they may provide initial evidence that YT may benefit adults treated for cancer. TRIAL REGISTRATION: ISRCTN registry, ISRCTN64763228. Registered on December 12, 2021. This trial was registered retrospectively. URL of trial registry record: https://www.isrctn.com/ISRCTN64763228.

Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: study protocol for a randomised, double-blind, placebo controlled clinical trial.

INTRODUCTION: COVID-19 has caused morbidity, hospitalisations and deaths worldwide. Despite four approved vaccines for COVID-19 in Canada, there is still a need for effective treatments, especially for people in the community. Vaccine efficacy is not 100% and long-term efficacy is still unknown. Furthermore, there are challenges to herd immunity including vaccine hesitancy and underlying conditions preventing vaccination. We aim to explore if the nutrients vitamin C, vitamin D, vitamin K2 and zinc are an effective treatment option for outpatients diagnosed with COVID-19. The primary outcome is the difference in participant-reported overall health; secondary outcomes include the effect on health status, symptom severity and duration, frequency and length of hospitalisations and mortality. METHODS AND ANALYSIS: This study is a two-arm, parallel-group, double-blind, placebo-controlled, phase III randomised controlled trial. 200 patients will be recruited remotely from COVID-19 test centres in Ottawa, Canada associated with The Ottawa Hospital. Overall health will be measured using the EuroQol Visual Assessment Scale; health status will be measured using the EuroQol 5-dimension 5-level questionnaire; symptom severity and duration will be measured using an independently developed questionnaire; analyses will use an area under the curve approach and compare mean scores using unadjusted t tests. Study data will be recorded on electronic case report forms using the Research Electronic Data Capture platform. An independent data safety and monitoring board will perform ongoing review of the study for feasibility and safety. ETHICS AND DISSEMINATION: This study has received ethical approval from the research ethics boards of the Canadian College of Naturopathic Medicine and the Ottawa Health Sciences Network, as well as regulatory approval from the Therapeutic Products Directorate and Natural and Non-Prescription Health Products Directorate of Health Canada. Results will be published in a peer-reviewed scientific journal with open access. TRIAL REGISTRATION NUMBER: NCT04780061.

Elderberry for prevention and treatment of viral respiratory illnesses: a systematic review.

BACKGROUND: Elderberry has traditionally been used to prevent and treat respiratory problems. During the COVID-19 pandemic, there has been interest in elderberry supplements to treat or prevent illness, but also concern that elderberry might overstimulate the immune system and increase the risk of 'cytokine storm'. We aimed to determine benefits and harms of elderberry for the prevention and treatment of viral respiratory infections, and to assess the relationship between elderberry supplements and negative health impacts associated with overproduction of pro-inflammatory cytokines. METHODS: We conducted a systematic review and searched six databases, four research registers, and two preprint sites for studies. Two reviewers independently assessed studies for inclusion, extracted data from studies, assessed risk of bias using Cochrane tools, and evaluated certainty of estimates using GRADE. Outcomes included new illnesses and the severity and duration of illness. RESULTS: We screened 1187 records and included five randomized trials on elderberry for the treatment or prevention of viral respiratory illness. We did not find any studies linking elderberry to clinical inflammatory outcomes. However, we found three studies measuring production of cytokines ex vivo after ingestion of elderberry. Elderberry may not reduce the risk of developing the common cold; it may reduce the duration and severity of colds, but the evidence is uncertain. Elderberry may reduce the duration of influenza but the evidence is uncertain. Compared to oseltamivir, an elderberry-containing product may be associated with a lower risk of influenza complications and adverse events. We did not find evidence on elderberry and clinical outcomes related to inflammation. However, we found evidence that elderberry has some effect on inflammatory markers, although this effect may decline with ongoing supplementation. One small study compared elderberry to diclofenac (a nonsteroidal anti-inflammatory drug) and provided some evidence that elderberry is as effective or less effective than diclofenac in cytokine reduction over time. CONCLUSIONS: Elderberry may be a safe option for treating viral respiratory illness, and there is no evidence that it overstimulates the immune system. However, the evidence on both benefits and harms is uncertain and information from recent and ongoing studies is necessary to make firm conclusions.

Adjuvant melatonin for the prevention of recurrence and mortality following lung cancer resection (AMPLCaRe): A randomized placebo controlled clinical trial.

BACKGROUND: Despite curative intent resection in patients with non-small cell lung cancer (NSCLC), recurrence leading to mortality remains too common. Melatonin has shown promise for the treatment of patients with lung cancer; however, its effect following cancer resection has not been studied. We evaluated if melatonin taken after complete resection reduces lung cancer recurrence and mortality, or impacts quality of life (QOL), symptomatology or immune function. METHODS: Participants received melatonin (20 mg) or placebo nightly for one year following surgical resection of primary NSCLC. The primary outcome was two-year disease-free survival (DFS). Secondary outcomes included five-year DFS, adverse events, QOL, fatigue, sleep, depression, anxiety, pain, and biomarkers assessing for immune function/inflammation. This study is registered at https://clinicaltrials.gov NCT00668707. FINDINGS: 709 patients across eight centres were randomized to melatonin (n = 356) versus placebo (n = 353). At two years, melatonin showed a relative risk of 1·01 (95% CI 0·83-1·22), p = 0·94 for DFS. At five years, melatonin showed a hazard ratio of 0·97 (95% CI 0·86-1·09), p = 0·84 for DFS. When stratified by cancer stage (I/II and III/IV), a hazard reduction of 25% (HR 0·75, 95% CI 0·61-0·92, p = 0·005) in five-year DFS was seen for participants in the treatment arm with advanced cancer (stage III/IV). No meaningful differences were seen in any other outcomes. INTERPRETATION: Adjuvant melatonin following resection of NSCLC does not affect DFS for patients with resected early stage NSCLC, yet may increase DFS in patients with late stage disease. Further study is needed to confirm this positive result. No beneficial effects were seen in QOL, symptoms, or immune function. FUNDING: This study was funded by the Lotte and John Hecht Memorial Foundation and the Gateway for Cancer Research Foundation.

A Prospective Outcomes Pilot Evaluation of Inspire Now: A Program for People with Lung Cancer.

BACKGROUND: Lung cancer is the leading cause of cancer mortality in Canada, yet patients are often under-supported. A six-week program called Inspire Now, created to address unmet supportive care needs, was evaluated in this study. Feasibility and preliminary outcomes were assessed in order to inform future changes to the program. OBJECTIVES: (1) Assess the feasibility of the program and its evaluation; (2) pilot the collection of patient-reported outcomes; (3) identify outcomes that may be positively influenced; and (4) inform program modifications. METHODS: Participants were recruited from the first session of Inspire Now for an observational pilot study. The primary outcome was feasibility. Secondary outcomes included within-person changes in Functional Assessment of Cancer Therapy - Lung (FACT-L) and Measure Yourself Concerns and Wellbeing (MYCaW), and program satisfaction and qualitative experiences of participants and facilitators through internally-developed questionnaires and semi-structured interviews. Analysis was primarily descriptive, within person changes in FACT-L and MYCaW were analyzed using the Wilcoxon signed-rank test and qualitative data was assessed for common themes. RESULTS: The program and its evaluation were feasible; 8 of 9 (89%) participants consented to the study, median attendance was 6 of 6 sessions (IQR 4.5-6), and questionnaire completion was 100% at baseline and 75% at follow-up. There were clinically meaningful improvements in MYCaW concern 1 (-1.2, 95% CI -2.0 to -0.4) and overall wellbeing (-0.9, 95% CI -2.1 to 0.4). Seven of eight FACT-L sub-sections trended toward improvement, with absolute changes ranging from -1.7 to 10.8%. Participant feedback was overwhelmingly positive; group support and social interactions were highly valued. CONCLUSIONS: The group intervention for people with lung cancer was feasible to both run and evaluate. Participants responded positively to the program. Findings will inform changes to future sessions and an analysis of multiple sessions is planned.

Naturopathic Oncology Care for Pediatric Cancers: A Practice Survey.

Background: The majority of pediatric oncology patients report use of complementary and alternative medicine. Some naturopathic doctors (NDs) provide supportive pediatric oncology care; however, little information exists to formally describe this clinical practice. A survey was conducted with members of the Oncology Association of Naturopathic Physicians (OncANP.org) to describe recommendations across four therapeutic domains: natural health products (NHPs), nutrition, physical medicine, and mental/emotional support. Results: We had 99 respondents with a wide variance of clinical experience and aptitude to treat children with cancer. Of the majority (52.5%) of respondents who choose not to treat these children, the three primary reasons for this are lack of public demand (45.1%), institutional or clinic restrictions (21.6%), and personal reasons/comfort (19.6%). The 10 most frequently considered NHPs by all NDs are fish-derived omega-3 fatty acid (83.3%), vitamin D (83.3%), probiotics (82.1%), melatonin (73.8%), vitamin C (72.6%), homeopathic Arnica (69.0%), turmeric/curcumin (67.9%), glutamine (66.7%), Astragalus membranaceus (64.3%), and Coriolus versicolor/PSK (polysaccharide K) extracts (61.9%). The top 5 nutritional recommendations are anti-inflammatory diets (77.9%), dairy restriction (66.2%), Mediterranean diet (66.2%), gluten restriction (61.8%), and ketogenic diet (57.4%). The top 5 physical modality interventions are exercise (94.1%), acupuncture (77.9%), acupressure (72.1%), craniosacral therapy (69.1%), and yoga (69.1%). The top 5 mental/emotional interventions are meditation (79.4%), art therapy (77.9%), mindfulness-based stress reduction (70.6%), music therapy (70.6%), and visualization therapy (67.6%). Conclusion: The results of our clinical practice survey highlight naturopathic interventions across four domains with a strong rationale for further inquiry in the care of children with cancer.

Intervention Development Process for a Pragmatic Randomized Controlled Trial: The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial.

BACKGROUND: Use of complementary therapies is high among people with cancer despite research gaps. The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial will evaluate the impact of an integrative care intervention delivered by naturopathic doctors (NDs) in conjunction with usual care for patients undergoing surgery for lung, gastric, and esophageal cancer. OBJECTIVES: To describe the multistep, multidisciplinary process of defining the integrative care intervention to be used in the Thoracic POISE trial using a principle-based approach that is pragmatic, holistic, safe, feasible, evidence driven, and consensus based. METHODS: An Intervention Development Committee (IDC) made up of a multidisciplinary team of health care providers (NDs, surgeons, oncologists, nurses, dietitians, physiotherapists, pharmacists, and psychologists), researchers, and patients was established to oversee the process. Potential intervention components were identified through a clinical practice survey and expert opinion. Systematic literature reviews were conducted and scores assigned based on the following criteria: usage, safety, goals, feasibility/scalability, and evidence. The IDC selected an intervention to be piloted that consists of a standard palette including core and optional components. Safety, known risks, and interactions with pharmaceuticals were evaluated using industry and professional monographs, a scoping literature review, and consultations with hospital pharmacists. RESULTS: The clinical practice survey and expert opinion identified 28 components for consideration. Following literature reviews, scoring, consensus from the IDC, and safety and interaction considerations, an intervention palette consisting of core and optional components was defined. The intervention options vary based on the patient's phase of treatment and symptom-specific needs. The intervention includes supplements, physical recommendations (exercise), nutritional counseling, and psychological support (audio scripts). CONCLUSION: Through a multistep, multidisciplinary process an integrative care intervention was developed for the Thoracic POISE trial. The intervention will be piloted in a single-arm feasibility study, followed by a single-center randomized controlled trial (RCT), and finally a multicenter RCT.

Integrative Oncology: International Perspectives.

Interest in integrative oncology (IO) is growing globally. Patients with cancer are actively using traditional complementary and integrative medicine (TCIM) as part of their cancer and survivorship care. Published studies from around the world report increasing use of TCIM by people living with cancer. This article summarizes the presentations that took place during a symposium titled, "Integrative Oncology: International Perspectives" at the International Research Congress on Integrative Medicine and Health in Baltimore, 2018. The purpose of the presentations was to examine whether cancer services across a variety of geographical regions, including Australia, Canada, the United States, and the European Union, were actively responding to cancer survivors' demand for TCIM. The presenters highlighted utilization rates and both facilitators and barriers to the provision of IO services in their respective countries and regions. The audience discussion following the presentations drew out many noteworthy perspectives.

North American naturopathic medicine in the 21st century: Time for a seventh guiding principle - Scientia Critica.

The World Health Organization strategy for global health includes a culturally-sensitive blending of western biomedicine with traditional forms of healing; in practical terms this approach is often referred to as integrative medicine. One distinct element within the systems of North American integrative healthcare is naturopathic medicine; while the basic premise of its fundamental approach to care - supporting healthy lifestyle behaviors - is as old as medicine itself, the early history of organized naturopathy in North America was heavy in theory and light on critical analysis. Dozens of questionable modalities and protocols have been housed under the rubric of naturopathy. It is our contention that the progression of professional naturopathic medicine in the 21st century - with goals of personal, public and planetary health - requires the active pursuit of critical analysis. We examine the primary guiding principles which drive the training and practice of North American naturopathic medicine; while these principles are laudable in the age of patient-centered care, we argue that there are shortcomings by absentia. We propose a seventh principle - Scientia Critica; that is, the ability to critically analyze accumulated knowledge - including scientific facts, knowledge about the self (critical consciousness) and values of the patient.

An N-of-1 Feasibility Study of Homeopathic Treatment for Fatigue in Patients Receiving Chemotherapy.

BACKGROUND: Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Homeopathy has been widely used to treat side effects of chemotherapy. The n-of-1 design is a single-patient trial method to study a clinical condition that is either short lived and reversible or is chronic and stable. The n-of-1 design requires a washout/reset period. The feasibility of performing an n-of-1 study in homeopathy has not previously been tested. METHODS: A feasibility n-of-1 trial of individualized homeopathic treatment for fatigue in a single adult undergoing chemotherapy administered periodically was performed. For each matched pair of treatments, the participant was randomly allocated either placebo or verum for the period between treatments. For the subsequent treatment period, the opposite allocation was given. Participant and practitioner were blinded to the allocation. Ongoing conventional treatments were permitted. The ability to recruit and retain was monitored and changes in fatigue and quality of life were measured using two validated outcome measures. RESULTS: Sixty-eight patients were assessed between February 2014 and February 2015. Four patients were eligible for the study and one consented to participate. The participant enrolled in the study for six cycles of chemotherapy and completed all treatment and outcome measures. There was no improvement under homeopathic treatment compared to placebo. There were multiple confounding events such as conventional medication changes and an adverse event unrelated to therapy. CONCLUSION: Adequate recruitment was not feasible in this setting. The n-of-1 study design is feasible in this population from the perspective of the ability to complete the trial. No conclusion on the efficacy of homeopathy for this individual can be made. It is unclear as to whether multiple treatments of chemotherapy would be an appropriate clinical situation in which to apply the n-of-1 trial methodology. Future studies should pilot adaptations to this study design.

Naturopathic Oncology Care for Thoracic Cancers: A Practice Survey.

BACKGROUND AND OBJECTIVES: There is a lack of information on therapies recommended by naturopathic doctors (NDs) for lung and gastroesophageal cancer care. Study objectives were to: (1) identify the most common interventions considered for use by NDs; (2) identify interventions NDs recommend to support key therapeutic goals; and (3) identify potential contraindications between integrative and conventional therapies. METHODS: Oncology Association of Naturopathic Physicians (OncANP) members (n = 351) were invited to complete an electronic survey. Respondents provided information on interventions considered for thoracic cancer pre- and postoperatively across 4 therapeutic domains (supplemental natural health products, physical, mental/emotional, and nutritional), therapeutic goals, and contraindications. This survey was part of the development of the Thoracic Perioperative Integrative Surgical Evaluation trial. RESULTS: Forty-four NDs completed the survey (12.5% response rate), all of whom were trained at accredited colleges in North America and the majority of whom were Fellows of the American Board of Naturopathic Oncology (FABNO) (56.8%). NDs identified significantly more interventions in the postoperative compared to preoperative setting. The most frequently identified interventions included modified citrus pectin, arnica, omega-3 fatty acids, vitamin D, probiotics, exercise, acupuncture, meditation, stress reduction, low glycemic index diet, and Mediterranean diet. Potential contraindications with conventional treatment (surgery, chemotherapy, radiotherapy) differed across natural health products. CONCLUSIONS: These findings highlight naturopathic interventions with a high level of use in thoracic cancer care, describe and characterize therapeutic goals and the interventions used to achieve these goals, and provide insight on how practice changes relative to conventional cancer treatment phase.

Clinical practice guidelines on the evidence-based use of integrative therapies during and after breast cancer treatment.

Answer questions and earn CME/CNE Patients with breast cancer commonly use complementary and integrative therapies as supportive care during cancer treatment and to manage treatment-related side effects. However, evidence supporting the use of such therapies in the oncology setting is limited. This report provides updated clinical practice guidelines from the Society for Integrative Oncology on the use of integrative therapies for specific clinical indications during and after breast cancer treatment, including anxiety/stress, depression/mood disorders, fatigue, quality of life/physical functioning, chemotherapy-induced nausea and vomiting, lymphedema, chemotherapy-induced peripheral neuropathy, pain, and sleep disturbance. Clinical practice guidelines are based on a systematic literature review from 1990 through 2015. Music therapy, meditation, stress management, and yoga are recommended for anxiety/stress reduction. Meditation, relaxation, yoga, massage, and music therapy are recommended for depression/mood disorders. Meditation and yoga are recommended to improve quality of life. Acupressure and acupuncture are recommended for reducing chemotherapy-induced nausea and vomiting. Acetyl-L-carnitine is not recommended to prevent chemotherapy-induced peripheral neuropathy due to a possibility of harm. No strong evidence supports the use of ingested dietary supplements to manage breast cancer treatment-related side effects. In summary, there is a growing body of evidence supporting the use of integrative therapies, especially mind-body therapies, as effective supportive care strategies during breast cancer treatment. Many integrative practices, however, remain understudied, with insufficient evidence to be definitively recommended or avoided. CA Cancer J Clin 2017;67:194-232. © 2017 American Cancer Society.

Fish-Derived Omega-3 Fatty Acids and Prostate Cancer: A Systematic Review.

BACKGROUND: The use of natural health products in prostate cancer (PrCa) is high despite a lack of evidence with respect to safety and efficacy. Fish-derived omega-3 fatty acids possess anti-inflammatory effects and preclinical data suggest a protective effect on PrCa incidence and progression; however, human studies have yielded conflicting results. METHODS: A search of OVID MEDLINE, Pre-MEDLINE, Embase, and the Allied and Complementary Medicine Database (AMED) was completed for human interventional or observational data assessing the safety and efficacy of fish-derived omega-3 fatty acids in the incidence and progression of PrCa. RESULTS: Of 1776 citations screened, 54 publications reporting on 44 studies were included for review and analysis: 4 reports of 3 randomized controlled trials, 1 nonrandomized clinical trial, 20 reports of 14 cohort studies, 26 reports of 23 case-control studies, and 3 case-cohort studies. The interventional studies using fish oil supplements in patients with PrCa showed no impact on prostate-specific antigen levels; however, 2 studies showed a decrease in inflammatory or other cancer markers. A small number of mild adverse events were reported and interactions with other interventions were not assessed. Cohort and case-control studies assessing the relationship between dietary fish intake and the risk of PrCa were equivocal. Cohort studies assessing the risk of PrCa mortality suggested an association between higher intake of fish and decreased risk of prostate cancer-related death. CONCLUSIONS: Current evidence is insufficient to suggest a relationship between fish-derived omega-3 fatty acid and risk of PrCa. An association between higher omega-3 intake and decreased PrCa mortality may be present but more research is needed. More intervention trials or observational studies with precisely measured exposure are needed to assess the impact of fish oil supplements and dietary fish-derived omega-3 fatty acid intake on safety, PrCa incidence, treatment, and progression.

Qualitative assessment of information and decision support needs for managing menopausal symptoms after breast cancer.

PURPOSE: For breast cancer (BrCa) survivors, premature menopause can result from conventional cancer treatment. Due to limited treatment options, survivors often turn to complementary therapies (CTs), but struggle to make informed decisions. In this study, we identified BrCa survivors' CT and general information and decision-making needs related to menopausal symptoms. METHODS: The needs assessment was informed by interpretive descriptive methodology. Focus groups with survivors (n = 22) and interviews with conventional (n = 12) and CT (n = 5) healthcare professionals (HCPs) were conducted at two Canadian urban cancer centers. Thematic, inductive analysis was conducted on the data. RESULTS: Menopausal symptoms have significant negative impact on BrCa survivors. Close to 70 % of the sample were currently using CTs, including mind-body therapies (45.5 %), natural health products (NHPs) and dietary therapies (31.8 %), and lifestyle interventions (36.4 %). However, BrCa survivors reported inadequate access to information on the safety and efficacy of CT options. Survivors also struggled in their efforts to discuss CT with HCPs, who had limited time and information to support women in their CT decisions. Concise and credible information about CTs was required by BrCa survivors to support them in making informed and safe decisions about using CTs for menopausal symptom management. CONCLUSIONS: High quality research is needed on the efficacy and safety of CTs in managing menopausal symptoms following BrCa treatment. Decision support strategies, such as patient decision aids (DAs), may help synthesize and translate evidence on CTs and promote shared decision-making between BrCa survivors and HCPs about the role of CTs in coping with menopause following cancer treatment.