Acupuncture for the treatment of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors: a feasibility trial.

PURPOSE: Breast cancer survivors following disease-modifying treatment frequently experience multiple-concurrent symptoms (Jansana et al. in Int J Cancer 149(10):1755 1767, 2021), negatively impacting their quality of life and increasing the risk of polypharmacy (Alwhaibi et al. in J Oncol Pharm Pract 26(5):1052 1059, 2020). This study evaluates the feasibility and acceptability of acupuncture for the management of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors, and investigates relationships between the symptom cluster and Traditional Chinese Medicine (TCM) syndrome diagnosis. METHODS: This was a single-arm, pre-test/post-test feasibility trial conducted at Chris O'Brien Lifehouse Hospital, Australia. Breast cancer survivors who completed treatment and experienced clinically significant levels of two or more symptoms (pain, fatigue, sleep disturbance, numbness/tingling) were eligible to participate in the individualized, pragmatic 6-week acupuncture intervention. The primary outcome was feasibility and acceptability. Effectiveness was explored using a symptom cluster mean score. RESULTS: Twenty women enrolled in the study over an 11-week period and 90% completed the study. Most women agreed or completely agreed that acupuncture was feasible (85%), acceptable (90%), and appropriate (90%). Both mean and composite symptom cluster scores were significantly reduced (p < 0.001), as were individual symptom scores in fatigue (p < 0.001), sleep disturbance (p = 0.04), and numbness/tingling (p = 0.01). TCM syndromes most closely associated with this symptom cluster were Spleen qi deficiency and Heart fire. No adverse events were reported. CONCLUSION: This study demonstrated that acupuncture was safe and feasible, justifying a powered randomized control trial. Preliminary findings suggest beneficial effects of acupuncture for the management of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster for women with breast cancer. TCM syndromes identified in this trial may be used to guide acupuncture treatment protocols. CLINICAL TRIAL REGISTRATION: This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000590763) on 21 April 2022.

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol.

INTRODUCTION: Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed 'prehabilitation') may mitigate these side effects and improve quality of life.During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that 'packaged' care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme. METHODS AND ANALYSIS: This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20-30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them. ETHICS AND DISSEMINATION: The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences. TRIAL REGISTRATION NUMBER: ACTRN12622000584730.

Acupuncture in cancer care: recommendations for safe practice (peer-reviewed expert opinion).

BACKGROUND: Up-to-date recommendations for the safe practice of acupuncture in integrative oncology are overdue with new cancer treatments and an increase in survivors with late effects of disease; 17 years have elapsed since Filshie and Hester's 2006 guidelines. During 2022/2023 an expert panel assembled to produce updated recommendations aiming to facilitate safe and appropriate care by acupuncturists working with people with cancer. METHODS: A core development team comprising three integrative oncology professionals comprehensively updated pre-existing unpublished recommendations. Twelve invited international experts (senior acupuncturists with and without experience of working in oncology settings, oncologists, physicians and nurses trained in integrative oncology, researchers, academics, and professional body representatives) reviewed the recommendations. In multiple iterations, the core team harmonised comments for final ratification. To aid dissemination and uptake the panel represents national and international integrative oncology associations and major cancer treatment centres in Europe, USA, Australia, and the Middle East. RESULTS: These recommendations facilitate safe care by articulating contra-indications, cautions, and risks for patients both on and off treatment (surgery, SACT, radiotherapy). Situations where acupuncture may be contra-indicated or practices need adapting are identified. "Red and Amber Flags" highlight where urgent referral is essential. CONCLUSION: These are the first international, multidisciplinary peer-reviewed recommendations for safe acupuncture practice in integrative oncology. Concerns about safety remain a significant barrier to appropriate referral from oncology teams, to use by acupuncturists and to uptake by patients. Disseminating trustworthy, widely accessible guidance should facilitate informed, confident practice of acupuncture in and outside of oncology healthcare settings.

Establishing an Integrative Oncology Service: Essential Aspects of Program Development.

PURPOSE OF REVIEW: Over the last 2 decades, integrative oncology (IO) has seen exponential growth within cancer care. It aims to combine evidence-based complementary therapies with conventional treatments to improve the well-being and quality of life for individuals dealing with cancer. The proliferation of integrative medicine programs in major cancer centers globally reflects varying approaches shaped by cultural, demographic, and resource-based factors. RECENT FINDINGS: Drawing upon the expertise of leaders in IO from the Society for Integrative Oncology (SIO) Clinical Practice Committee, this manuscript serves as a practical guide for establishing an IO practice. Collating insights from diverse professionals, including oncologists, integrative oncologists, supportive care physicians, researchers, and clinicians, the paper aims to provide a comprehensive roadmap for initiating and advancing IO services. The primary objective is to bridge the gap between conventional cancer care and complementary therapies, fostering a patient-centric approach to address the multifaceted challenges encountered by individuals with cancer. This paper delineates several key sections elucidating different aspects of IO practice. It delves into the core components necessary for an IO service's foundation, outlines the initial medical consultation process, and presents crucial tools essential for successful consultations. By consolidating insights and expertise, this manuscript seeks to facilitate the integration of IO into mainstream cancer care, ultimately enhancing patient outcomes and experiences.

Electroacupuncture use for treatment of taxane-induced peripheral neuropathy in patients with breast cancer: protocol for a pilot, randomised, blinded, sham-controlled trial (EA for CIPN).

INTRODUCTION: Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect of neurotoxic chemotherapy. Acute symptoms of CIPN during treatment can lead to dose reduction and cessation. Trials using electroacupuncture (EA) to treat established CIPN postchemotherapy have shown some efficacy. The current trial aims to assess the feasibility and preliminary efficacy of using EA to treat CIPN during chemotherapy. METHODS AND ANALYSIS: The current study is a single-centre, 1:1 randomised, sham-controlled pilot study set in a tertiary cancer hospital in Sydney, Australia, and will recruit 40 adult patients with early breast cancer undergoing adjuvant or neoadjuvant paclitaxel chemotherapy. Patients who develop CIPN within the first 6 weeks of chemotherapy will receive either true EA or sham-EA once a week for 10 weeks. The coprimary endpoints are recruitment and adherence rate, successful blinding of patients and compliance with the follow-up period. Secondary endpoints are mean change of CIPN symptoms from randomisation to end of treatment, sustained change in CIPN symptoms at 8-week and 24-week follow-up postchemotherapy, proportion of subjects attaining completion of 12 weeks of chemotherapy without dose reduction or cessation, change in acupuncture expectancy response pretreatment, during treatment and posttreatment. The primary assessment tool for the secondary endpoints will be a validated patient-reported outcome measure (European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy) captured weekly from randomisation to week 12 of chemotherapy. ETHICS AND DISSEMINATION: The study protocol (2021/ETH12123) has been approved by the institutional Human Research Ethics Committee at St Vincent's Hospital Sydney and Chris O'Brien Lifehouse. Informed consent will be obtained prior to starting study-related procedures. The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12622000081718.

Knowledge and attitudes towards medicinal cannabis and complementary and integrative medicine (CIM): a survey of healthcare professionals working in a cancer hospital in Australia.

PURPOSE: We investigated attitudes and practices of healthcare professionals (HCPs) to medicinal cannabis (MC) and complementary and integrative medicine (CIM), including individual therapies, such as acupuncture, massage, herbs, dietary supplements, nutrition and exercise. We explored whether healthcare occupation influenced attitudes to CIM and MC; referral pathways for advice on CIM; and interest in a pharmacy service to evaluate herbs and supplements. METHODS: Cross-sectional survey. All clinical staff at a comprehensive cancer hospital were invited to complete an anonymous questionnaire about CIM and MC. We used descriptive analysis to describe the respondent's knowledge and attitudes, and Fisher's exact test to test for differences by occupation, length of time at the hospital and age. RESULTS: Most of the 116 HCPs respondents supported integrating CIM into cancer care (94.8%) and wanted to learn more (90%) and to understand benefits and contraindications. Most respondents believed that CIM (87.9%) could benefit patients with cancer, and MC could benefit those with advanced cancer (49-51%). Whilst just over half (52.6%) felt confident discussing CIM with patients, only 10% felt they had sufficient knowledge to discuss MC. Most felt they did not have sufficient knowledge to specifically discuss mind and body practices (63.8%) or herbs and supplements (79%). HCPs (63%) would be more inclined to allow use of herbs and supplements with cancer treatment if a pharmacy service was available to evaluate interactions. Occupation, length of time at hospital and age influenced confidence and knowledge about CIM. CONCLUSIONS: The integration of evidence-based CIM and MC into cancer care is hampered by a lack of knowledge of benefits and contraindications, and gaps in education. Effective and safe integration may require targeted development of services such as pharmacy to evaluate the safety of herbs and supplements, and inclusion of cancer specialists who have received training in individual CIM therapies and MC.

Exploring a multi-disciplinary model of supportive cancer care for monoclonal antibody treatment-related dermatological symptoms.

CONTEXT AND OBJECTIVES: The present study examined the perspectives of healthcare providers (HCPs) in designing a multi-disciplinary model of supportive cancer care for the relief of dermatology-related symptoms caused by monoclonal antibody therapies. METHODS: The study employed a mixed research methodology, with qualitative research embedded within a pragmatic prospective study of a registry protocol study. Patients undergoing oncology therapy with MoAB, anti-HER2, and anti-PD-L1 monoclonal antibodies were identified among a cohort of patients referred to an integrative oncology (IO) consultation for symptom relief and improved quality of life (QoL). Case studies with significant dermatology-related concerns were selected and presented to a panel of 6 HCPs trained in medical oncology, oncology nursing, family medicine, supportive cancer care, and IO. HCP narratives were qualitatively analyzed and assessed using ATLAS.Ti software for systematic coding. RESULTS: Of the 924 patients referred to the IO consultation, 208 were treated with monoclonal antibodies, from which 50 were selected for further evaluation. Of these, 7 cases were presented to the HCP team who were asked to identify treatment gaps requiring a multi-disciplinary approach. Qualitative analysis identified 3 major themes: a biophysical perspective; a psycho-social-spiritual perspective; and the implementation of integrated care. DISCUSSION: There is a need for a multi-disciplinary approach when treating patients suffering from monoclonal antibody treatment-related skin toxicities. HCP-reported themes highlight the need to identify patients for whom such an approach is warranted; conditions in which a psycho-social-spiritual perspective should be considered, in addition to a bio-physical approach; and considerations of who should be designated as the patient's primary case manager.

Cancer survivors' experiences, barriers and preferences with yoga: A cross-sectional survey to inform a yoga intervention.

PURPOSE: Evidence suggests that yoga may help improve cancer-related symptoms though knowledge of the experiences, barriers and preferences of people diagnosed with cancer is limited. This study sought to examine the use of yoga in an Australian sample and identify the experiences and preferences associated with undertaking yoga practice as formative research to help inform a future yoga intervention. METHODS: Adults diagnosed with any type of cancer completed a cross-sectional survey including questions regarding their demographics, experiences and preferences for yoga practice. RESULTS: Sixty-eight people who had been diagnosed with cancer completed the survey. Most of the participants (70.8%) had practiced yoga since their diagnosis. A variety of reasons for practice were endorsed, and benefits experienced included physical and psychological factors. The most common barrier to practice was related to the physical ability to undertake yoga. Participants indicated a preference for group classes (44.1%), with a frequency of practice of 2-3 times per week (60.3%), 60 min in length (75%). The preferred time of practice was 9am-12pm (51.5%) and travel distance 5-10 km (44.1%). Online yoga delivery was endorsed, with participants preferring pre-recorded sessions. CONCLUSIONS: Results from this study provide insights into the experiences, barriers and preferences for yoga practice in people with cancer which will assist in developing yoga programs in this cohort to investigate the effects on cancer and treatment-related symptoms.

Acupuncture and Reflexology for Patients Undergoing Chemotherapy: A Cohort Study.

PURPOSE: Around three quarters of individuals undergoing chemotherapy self-report multiple symptoms. There is clinical trial evidence of effectiveness for acupuncture for commonly experienced symptoms, and emerging evidence for reflexology, but little is known about the effects of these therapies on multiple symptoms when implemented in a real world setting during active chemotherapy treatment. METHODS: This was a cohort study of participants receiving reflexology and/or acupuncture while attending chemotherapy. Participants received a 20 minute reflexology treatment or a 20 minute acupuncture treatment or a combination of both. Patient reported outcome measures were administered before and after the treatment using the Edmonton Symptom Assessment Scale (ESAS). RESULTS: During the study period, 330 unique patients received a total of 809 acupuncture and/or reflexology treatments. Participants had, on average, 5.3 symptoms each which they reported as moderate to severe (≥4/10) using the ESAS at baseline. Following treatment, participants reported 3.2 symptoms as moderate to severe. The symptom change for all participant encounters receiving any therapy was statistically significant for all symptoms, and clinically significant (a reduction of more than 1) for all symptoms except financial distress, appetite, and memory. Clinically significant levels of global distress (<3) were reduced in 72% of all participants receiving either therapy. No adverse events were recorded. CONCLUSIONS: The results indicate that acupuncture and reflexology administered alongside chemotherapy may reduce patient reported symptom burden and patient global symptom related distress. Future research would include an active control group, and consider confounding factors such as chemotherapy stage and medication.

"What Should I Eat?"-Addressing Questions and Challenges Related to Nutrition in the Integrative Oncology Setting.

PURPOSE OF REVIEW: This review aims to assess how nutrition can be addressed in the integrative oncology setting, taking into account cancer patients' unmet needs as they relate to nutrition in cancer care and the evidence-based information that is available on this topic. RECENT FINDINGS: During and after cancer treatment, nutrition is an important component of supportive care, for patients and their family members. Current scientific data consistently show that poor nutrition can reduce survival and decrease adherence to cancer treatments. Unfortunately, the limited availability of dietitians makes access to individualized nutrition counseling challenging, and many cancer patients still do not receive adequate nutritional support. As a result, one of the main unmet needs of patients and their families through the whole cancer trajectory is accessible and up-to-date evidence-based nutritional counseling that emphasizes basic healthy nutrition. The popularity of complementary and integrative medicine among patients with cancer makes the integrative oncology setting an excellent avenue for providing such support. A suggested simple approach that utilizes World Cancer Research Fund/American Institute for Cancer Research and American Cancer Society basic information is described. This approach can be easily incorporated into integrative oncology settings, while reserving the role for the registered dietician to address underweight patients, patients with malnutrition, and patients with more complicated dietary situations. The integrative oncology setting is in a unique place in oncology that can be utilized for enhancing dissemination of healthy nutrition information and addressing the unmet needs expressed by patients and families.

A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With High Grade Gliomas.

BACKGROUND: Cannabis for cancer is very topical and, given the use of illicit cannabis preparations used in this vulnerable population, research investigating standardised, quality-assured medicinal cannabis is critical to inform clinicians and assist patient safety. METHODS: A randomized trial involving adult patients diagnosed with a high-grade glioma, no history of substance abuse, liver or kidney damage or myocardial infarction were eligible for inclusion in a tolerability study on two different ratios of medicinal cannabis. Baseline screening of brain morphology, blood pathology, functional status, and cognition was conducted. A retrospective control group was used for comparison for secondary outcomes. RESULTS: Participants (n=88) were on average 53.3 years old. A paired t-test assessed the Functional Assessment of Cancer Therapy for Brain Cancer (FACT-Br) between groups from baseline to week 12 found that the 1:1 ratio favoured both physical (p=0.025) and functional (p=0.014) capacity and improved sleep (p=0.009). Analysis of changes from baseline to week 12 also found 11% of 61 participants had a reduction in disease, 34% were stable, 16% had slight enhancement, and 10% had progressive disease. No serious adverse events occurred. Side effects included dry mouth, tiredness at night, dizziness, drowsiness. CONCLUSION: This study demonstrated that a single nightly dose of THC-containing medicinal cannabis was safe, had no serious adverse effects and was well tolerated in patients. Medicinal cannabis significantly improved sleep, functional wellbeing, and quality of life. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373556&isReview=true, identifier ACTRN12617001287325.

Characteristics and Symptom Burden of Patients Accessing Acupuncture Services at a Cancer Hospital.

BACKGROUND: Patients with cancer are often impacted by a significant symptom burden. Cancer hospitals increasingly recognize the value of complementary and integrative therapies to support the management of cancer related symptoms. The aim of this study is to provide a better understanding of the demographic characteristics and symptoms experienced by cancer patients who access acupuncture services in a tertiary hospital in Australia. METHODS: A retrospective audit was conducted of patients that presented to the acupuncture service at Chris O'Brien Lifehouse between July 2017 and December 2018. Edmonton Symptom Assessment Scale (ESAS) and Measure Yourself Concerns and Wellbeing (MYCaW) outcome measures were used. The quantitative data was analyzed using descriptive statistics and Principal Component Analysis. RESULTS: A total of 127 inpatients and outpatients (mean age 55, range 19-85) were included with 441 individual surveys completed (264 ESAS, 177 MYCaW). Patients were predominantly female (76.8%) and breast cancer was the most prevalent primary diagnosis (48%). The most prevalent symptoms in the ESAS were sleep problems (88.6%), fatigue (88.3%), lack of wellbeing (88.1%), and memory difficulty (82.6%). Similarly, symptoms with the highest mean scores were numbness, fatigue, sleep problems and hot flushes, whilst neuropathy, and hot flashes were scored as the most severe (score ≥7) by patients. Cluster analysis yielded 3 symptom clusters, 2 included "physical symptoms" (pain, sleep problems, fatigue and numbness/neuropathy), and (nausea, appetite, general well-being), whilst the third included "psychological" symptoms (anxiety, depression, spiritual pain, financial distress). The most frequent concerns expressed by patients (MyCaW) seeking acupuncture were side effects of chemotherapy (24.6%) and pain (20.8%). CONCLUSION: This audit highlights the most prevalent symptoms, the symptoms with the greatest burden and the types of patients that receive acupuncture services at an Australian tertiary hospital setting. The findings of this audit provide direction for future acupuncture practices and research in hospital settings.

Yoga for depression and anxiety symptoms in people with cancer: A systematic review and meta-analysis.

OBJECTIVE: Cancer and its treatment can lead to a variety of physical and emotional concerns impacting on those affected, including subclinical or clinical depression and anxiety, which in turn have a significant impact on wellbeing, quality of life and survival. The aim of this review was to evaluate the effect of yoga-based interventions on self-reported depression and anxiety symptoms in people with cancer in randomized controlled trials. METHOD: Six databases were searched to identify relevant studies. Systematic review procedures were followed including a quality assessment. Meta-analysis of suitable studies was conducted. RESULTS: 26 studies from our search criteria were eligible for inclusion for depressive and 16 for anxiety symptoms. Meta-analyses revealed evidence for significant medium effects of yoga on depression symptoms (N = 1,486, g = -0.419, 95% confidence interval [CI] = -0.558 to -0.281, p < 0.001) and anxiety (N = 977, g = -0.347, 95% CI = -0.473 to -0.221, p < 0.001) compared to controls. Subgroup analyses for depressive symptoms revealed significant effects for all analyses performed (type of cancer, type of control, treatment status, duration of intervention or frequency of yoga sessions), with effect sizes being comparable between subgroups. Similar findings were found for anxiety symptoms except for treatment status, where the only significant effect was found when yoga was delivered during active treatment. CONCLUSIONS: This review provides evidence that in people with cancer, yoga-based interventions are associated with amelioration of depression and anxiety symptoms and therefore a promising therapeutic modality for their management. However, the potential for risk of bias together with control group design challenges means the results should be interpreted with caution.

Patient-reported outcome measures and supportive care need assessment in patients attending an Australian comprehensive care centre: a multi-method study.

PURPOSE: Patient-reported outcome measures (PROMs) are useful clinical tools to recognise symptoms, patient needs and their severity. Whilst PROMs are routinely utilised in integrative oncology (IO) and supportive care (SC) services to improve patient care, they are not as common in general oncology. We explored our patients' symptom burden, the approach taken by clinicians to identify and manage patient needs, and barriers and facilitators to using PROMs in an Australian tertiary comprehensive cancer centre to inform wider implementation of PROMs. METHODS: From 2017 to 2018, PROM data collected for patients accessing IO and SC was retrospectively analysed. Semi-structured interviews with oncology doctors and nurses explored their approach to patient needs assessment and their use of PROMs. RESULTS: A total of 404 patients completed the Edmonton Symptom Assessment Scale (ESAS). The most frequently identified symptoms were sleep disturbance, fatigue and lack of wellbeing. Symptom clusters included drowsiness, fatigue and shortness of breath; anxiety and depression; sleep and pain; appetite and nausea. In total, 9 nurse consultants, 5 surgeons, 7 medical and 5 radiation oncologists were interviewed. Most participants took an intuitive approach to identifying and managing patient needs and did not routinely use PROMs. Perceived risks, barriers and facilitators to using PROMS are presented. CONCLUSIONS: High and complex symptom burden was found in our IO and SC patient population, reinforcing the need for screening. Whilst wider clinical use of PROMs within the hospital may improve clinical outcomes, the barriers and facilitators identified by Health Care Professionals (HCPs) need to be addressed before implementing PROMs more broadly.

Clinical trials with cannabis medicines-guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience.

With cannabis medicines now obtaining legal status in many international jurisdictions (generally on the authorisation of a medical professional), a rapid increase in consumer demand for access to cannabis as a therapeutic option in the treatment and management of a range of indications is being noted. Despite this accessibility, knowledge on optimal use is lacking. Further drug development and clinical trials at regulatory standards are necessary both if a better understanding of the efficacy of cannabis medicines, optimal product formulation and indication-specific dosing is needed and to ensure the broader quality and safety of cannabis medicines in the clinical setting.To enable this, clinical, academic and public calls for the undertaking of rigorous clinical trials to establish an evidence base for the therapeutic use of cannabis medicines have been made internationally. While this commitment to undertake human studies with cannabis medicines is welcomed, it has highlighted unique challenges, notably in the review stages of ethics and governance. This often results in lengthy delays to approval by Human Research Ethics Committees (herein 'HREC', Australia's nomenclature for Institutional Review Boards) and trial commencement. A principal concern in these cases is that in contrast to clinical trials using other more conventional pharmaceutical products, trials of cannabis medicines in humans often involve the use of an investigational product prior to some (or any) of the preclinical and pharmaceutical safety issues being established. This paucity of data around product safety, potential drug interactions, continuity of supply, shelf life and product storage results in apprehension by HRECs and governance bodies to endorse trials using cannabis medicines.This manuscript draws from the experiences of Australian researchers and staff involved in clinical trials of cannabis medicines to describe some of the common difficulties that may be faced in the HREC approval process. It also presents practical advice aimed to assist researchers, HRECs and governance officers navigate this complex terrain. While the authors' experiences are situated within the Australian setting, many of the barriers described are applicable within the international context and thus, the solutions that have been proposed are typically adaptive for use within other jurisdictions.

Integrative Medicine: Adjunctive Element or Essential Ingredient in Palliative and Supportive Cancer Care?

The aim of supportive cancer care is to actively manage patients' physical, psychologic, and spiritual concerns, independent of prognosis. Complementary and integrative medicine (CIM) is increasingly gaining greater acceptance and support for its beneficial value in supportive cancer care. The utilization of CIM early in the cancer trajectory, during treatment and during survivorship periods, as well as during end of life, addresses a great number of unmet needs that patients affected by cancer raise. In addition, recent research supports the role that CIM has in reducing suffering and distress both physically and emotionally, as well as enhancing well-being in patients affected by cancer and their families. CIM is increasingly seen not only as an adjunctive add-on treatment or perhaps even as a luxury item for the affluent but actually as an important component in supportive cancer care for all patients. It addresses many aspects of care that sometimes are not being addressed with conventional means. With the increase in CIM-related research, as well as the increased clinical experience in oncology programs worldwide, CIM is gradually becoming an essential ingredient in supportive and palliative cancer care. In this narrative review, the authors look systematically at the contribution that CIM has in supportive care in each stage of the cancer trajectory, reflecting the needed role that CIM has in supportive care. The presented data will provide a sampling of the available clinical research for each of the broad stages being described.

Patient-Reported Outcomes in Integrative Oncology: Bridging Clinical Care With Research.

There is growing interest in the value of routine collection and monitoring of patient-reported outcomes as part of high-quality, patient-centered, oncology care. Integrative oncology, with its focus on providing symptom and lifestyle support for patients throughout the cancer care continuum, serves a diverse patient population with a complex, changing symptom burden. Monitoring of patient-reported outcomes can contribute significantly to the successful comprehensive evaluation and management of patients receiving integrative oncology care. Data collected as part of an integrative oncology evaluation can also support real-world clinical research efforts to help learn more about the effects of integrative oncology interventions on patient symptoms, quality of life, and treatment outcomes.

A supportive care intervention for people with metastatic melanoma being treated with immunotherapy: a pilot study assessing feasibility, perceived benefit, and acceptability.

INTRODUCTION: Increasing numbers of metastatic melanoma (MM) patients are receiving immunotherapy treatment, including pembrolizumab, and the impact on their well-being is underexplored. OBJECTIVES: To assess the feasibility of a multimodal supportive care program to MM patients being treated with pembrolizumab. METHODS: This pre-post-test feasibility cohort study recruited MM participants treated with pembrolizumab: (i) supportive care intervention with usual care and (ii) usual care. The intervention comprised comprehensive medical assessment by supportive care physician (SCP), exercise physiologist (EP), and dietitian then a tailored supportive care program. Programs included exercise, dietary advice, non-invasive complementary therapies, and psychology consultation. Outcome measures included adherence, patient-reported symptoms, anxiety and depression, and toxicity. Descriptive data are reported. RESULTS: We recruited 28 participants: 13 intervention and 15 control; three did not complete the study. Most were male, with median age 66 (range 42-85) years. All intervention participants completed baseline assessments with SCP, EP, and dietitian. Two missed follow-up with EP or dietitian. Symptoms most troubling at baseline were as follows: fatigue (n = 6), sleep (n = 6), general aches and pains (n = 5), and memory (n = 4). All intervention participants were prescribed 16 exercise sessions; 8 (50%) completed all; overall exercise adherence was 85%. Integrative therapies were accessed by 85% (11) participants. Immunotherapy-related adverse event rates were low and SCP consultation identified symptoms not captured by CTCAE 4.0. CONCLUSIONS: A holistic supportive care intervention tailored to individual needs is feasible. The symptom burden in MM patients was low. Further investigation of the intervention is warranted, focused on populations with higher symptom burden to improve outcomes.

Certainty within uncertainty: a qualitative study of the experience of metastatic melanoma patients undergoing pembrolizumab immunotherapy.

OBJECTIVE: Little is known about the lived experiences of patients with metastatic melanoma undergoing checkpoint inhibitor treatment. We conducted a feasibility study of a supportive care intervention for melanoma patients being treated with pembrolizumab. Here, we report a secondary objective of the study, which was to explore the lived experience of being on pembrolizumab treatment for advanced melanoma. METHODS: Twenty-eight participants with metastatic melanoma were recruited across two cohorts, all receiving 3-weekly immunotherapy treatment. Semi-structured interviews were conducted with 26 participants once at 9 weeks. Thematic analysis using interpretative phenomenological analysis (IPA) was performed with multiple iterations of data review to achieve consensus. RESULTS: Three overarching themes were identified; here, we report the first and most dominant theme: how metastatic melanoma patients live within uncertain spaces. Although immunotherapy increases overall survival, metastatic melanoma patients live within an uncertain spectrum. They confront uncertainty related to immunotherapy treatment, their disease trajectory, family relationships, and decision-making. Melanoma patients attempt to normalize their lives, engaging in their usual activities. Uncertainty increases prior to active treatment and intensifies during investigation phases. CONCLUSIONS: Despite progress in melanoma patient treatment and outcomes, these patients face sustained uncertainty about their disease trajectory.

Establishing an integrative oncology service in the Australian healthcare setting-the Chris O'Brien Lifehouse Hospital experience.

Comprehensive cancer centres are on the rise as patients seek a more holistic approach to maintaining their wellbeing when living with a cancer diagnosis. Many cancer centres worldwide now incorporate a selection of evidence-based complementary therapies and qualified therapists into their offerings. The Chris O'Brien Lifehouse, a comprehensive cancer centre in Sydney, Australia, provides integrative oncology services including acupuncture, massage, reflexology, dietetics and exercise physiology for individual patients, along with group programmes, and an integrative and supportive care medical specialist. The purpose of this paper is to reflect on one model of integrative oncology service and approach to integration and team and service development.