A systematic review of integrative clinical trials for supportive care in pediatric oncology: a report from the International Society of Pediatric Oncology, T&CM collaborative.

PURPOSE: Traditional and complementary medicine (T&CM) use in children with cancer is well established among high-income, upper middle-income, low-middle-income, and low-income countries (HIC, UMIC, LMIC, LIC, respectively). In HIC, a developing body of evidence exists for several T&CM therapies; however, evidence in other income settings is less well described despite a significantly higher use when compared to reports from HIC. The aim of this systematic review was to evaluate the evidence for T&CM for a variety of supportive care indications among children with cancer. METHODS: We performed a systematic review following the PRISMA guidelines of randomized, controlled clinical trials from inception through September 2016. Our eligibility criteria were limited to T&CM studies performed in children and adolescents undergoing treatment for a pediatric malignancy. RESULTS: Of 6342 studies identified, 44 met inclusion criteria. Two clinical trials reported on acupuncture, 1 reported on aromatherapy, 9 evaluated massage therapy, and 32 reported on dietary supplements. Twenty-two studies were performed in HIC, 15 in UMIC, and 7 in LMIC. T&CM therapies were most commonly investigated for the prevention or management of mucositis, weight loss, and febrile neutropenia. Encouraging results were reported for select interventions; however, the majority of studies were classified as poor to fair quality. CONCLUSION: Our search revealed numerous clinical studies investigating the use of T&CM for supportive care purposes in pediatric oncology in HIC, UMIC, and LMIC. Although limited, these results could inform supportive care resource allocation and indicate where T&CM may serve to fill gaps where access to care may be limited.

Predictors of acupuncture use among children and adolescents with cancer.

BACKGROUND: Evidence for the application of acupuncture in pediatric oncology is limited. We investigated the acceptance of acupuncture and factors associated with its use among children and adolescents with cancer. METHODS: Ninety acupuncture-naïve children receiving cancer treatment at Columbia University Medical Center (CUMC) provided consent/assent for participation. Participants could choose to receive or refuse integrative services offered at CUMC. Symptoms were collected for a 6-month period with the Memorial Symptom Assessment Scale (MSAS). Acute and delayed adverse events among participants who received acupuncture were recorded. RESULTS: Fifty-four percent of the participants elected to receive acupuncture. In total, 252 acupuncture sessions were administered with a median of four sessions per patient (range 1-13 sessions). Pain (56%), nausea (51%), lack of energy (50%), and irritability (43%) were the most frequently reported symptoms in the whole cohort. Determinants of acupuncture use included older age and ethnicity. Acupuncture was more likely than other integrative modalities to be used for gastrointestinal and constitutional symptoms including drowsiness (odds ratio [OR], 3.34; 95% confidence interval [CI], 1.98-5.66; P < 0.0001), lack of energy (OR, 3.23; 95% CI, 1.78-5.87; P = 0.0001), and pain (OR, 2.63; 95% CI, 1.46-4.72; P = 0.001). Adverse events were reported by 3% of the participants. There was no increased incidence of adverse events in children with thrombocytopenia (P = 0.189) or neutropenia (P = 0.497). CONCLUSION: Our results highlight the potential use of acupuncture as a safe, adjunctive therapy for symptom management within existing supportive care regimens in pediatric oncology and potential areas to focus research initiatives.

Use of acupuncture with acupressure in addition to standard-of-care cryotherapy to decrease chemotherapy-associated neuropathy in patients with gastrointestinal malignancies receiving oxaliplatin-based chemotherapy: Study protocol for a randomized, controlled pilot and feasibility study.

BACKGROUND: Oxaliplatin is a key chemotherapeutic agent in the treatment of local and metastatic gastrointestinal (GI) malignancies. Dose density and treatment adherence can be limited by chemotherapy-induced peripheral neuropathy (CIPN). Early research suggests CIPN incidence and severity may be mitigated by acupuncture, but rigorous data in GI oncology patients is limited. Here, we describe the protocol of a randomized, waitlist-controlled pilot study testing the use of preemptive of acupuncture plus acupressure to decrease CIPN and chemotherapy-related toxicities. METHODS: Patients with a GI malignancy (n = 56) with planned 5-fluorouracil (5-FU) and oxaliplatin IV (FOLFOX, FOLFIRINOX) every 2 weeks are being recruited. Additional concurrent anti-neoplastic agents may be used. Enrolled patients are randomized 1:1 to a 3-month intervention of Arm A: acupuncture with acupressure and standard-of-care treatment, or Arm B: standard-of-care alone. In Arm A, on days 1 and 3 of each chemotherapy cycle a standardized acupuncture protocol is administered and patients are taught self-acupressure to perform daily between chemotherapy treatments. Patients in both arms are given standard-of-care oral and peripheral (hands/feet) ice chip cryotherapy during oxaliplatin administration. CIPN and other symptoms are assessed at baseline, 6 weeks, and 3 months from registration. The primary endpoint is CIPN severity at 3 months (EORTC-CIPN 20). Additional endpoints evaluate CIPN incidence (CTCAE, Neuropen, tuning fork); incidence of pain, fatigue, nausea, oral dysesthesia, and anxiety; and feasibility (recruitment, retention, adherence, acceptability). If warranted, trial results will inform the design of a multi-center trial to expand testing of the intervention to a larger patient cohort.

SEAttle-based Research of Chinese Herbs for COVID-19 Study: A Whole Health Perspective on Chinese Herbal Medicine for Symptoms that may be Related to COVID-19.

INTRODUCTION: East Asian Medicine (EAM) is a Whole System medicine that includes Chinese herbal medicine (CHM). Chinese herbal medicine has been utilized to reduce symptom burden in infectious disease, with notable theoretical reformulations during pandemics of the 3rd, 13th, and 17th centuries. Today, Licensed Acupuncturists trained in CHM have utilized it to treat symptoms and sequelae of COVID-19. However, little is known about its use or efficacy by the public and health practitioners. Understanding and evaluating whole medicine systems of healthcare is inherently complex; there is international consensus for a descriptive, pragmatic approach. We are conducting a feasibility pilot study using a prospective, pragmatic, observational design using Whole Health and Whole Person perspectives. The complexity of COVID-19 reflects the impact on multiple homeoregulatory systems and provides a unique opportunity to assess the impact of interventions such as EAM on whole health. Observation of these EAM encounters will provide valuable qualitative and quantitative data on the interface of an extant Whole System medicine with a novel complex illness as a precursor to a randomized clinical trial. METHODS: This ongoing study observes a CHM clinic offering telehealth consultations to a diverse patient population since April, 2020. Patients who report symptoms potentially related to COVID-19 disease are consented for standardized collection and analysis of demographic and clinical data from each clinical encounter. RESULTS: To date, 61 patients engaged in 195 consultations (mean 3.3) with 49 reporting symptom resolution sufficient to complete treatment, and 4 withdrawals. Just over half (62%) were female, with an average age of 45.7 years. A wide variety of CHM formulas and EAM dietary and lifestyle modifications were provided. DISCUSSION: Adequate recruitment and retention suggest feasibility of the intervention and data collection. The rich dataset may facilitate the construction of Whole Health models of CHM's clinical impact, as well as integrative inquiry into CHM's effects on symptoms.

Acupuncture Intervention Protocol: Consensus Process for a Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults: An NIH HEAL Initiative Funded Project.

OBJECTIVE: The aim of this article is to describe the consensus process used to develop an acupuncture intervention protocol for an NIH-funded pragmatic randomized controlled trial (PRCT) of acupuncture for the management of chronic low back (cLBP) in older adults (BackInAction). BACKGROUND: CLBP is among leading causes of disability worldwide: almost 33% of US adults 65 and older experience LBP. Acupuncture is effective for cLBP but there is no specific data on older adults. The National Institutes for Health (NIH) funded a PRCT of acupuncture needling for this population. An essential trial milestone was development of a consensus intervention protocol. METHODS: An Acupuncture Advisory Panel (AAP) was formed with nine members: two physician-acupuncturists, six licensed acupuncturists representing diverse work backgrounds, and an acupuncture researcher. We used a modified Delphi process that included provision of acupuncture trial data, survey data describing how each expert treats cLBP, three conference calls, and between-call email discussion. RESULTS: Lively and professional discussions led to a consensus intervention protocol for the BackInAction trial that included steps/staging of care, recommendations for parameters of care session length, number of needle insertion sites, insertion depths, needle retention times, recommended types of needles, both local and distal areas of the body to be treated, acupuncture point options, auricular point options, self-care options, and minimum number of sessions considered ideal. CONCLUSION: Using a modified Delphi process, an expert AAP created a consensus intervention protocol for the PRCT of acupuncture needling for cLBP in patients 65 and older.

The safety of acupuncture in children and adolescents with cancer therapy-related thrombocytopenia.

PURPOSE: Acupuncture is frequently used to manage the side effects associated with cancer therapy. In acupuncture practice, the presence of thrombocytopenia is a relative contraindication to acupuncture use among patients with cancer. However, the safety of acupuncture in patients with cancer treatment-related thrombocytopenia has not been previously investigated. METHODS: Medical records of 32 patients receiving acupuncture at an academic medical center with an established acupuncture program during treatment for cancer or during stem cell transplantation were reviewed. RESULTS: Of 237 acupuncture sessions, 20%, 8%, and 19% of the sessions were administered to patients with severe, moderate, and mild thrombocytopenia, respectively. No bleeding side effects were observed. CONCLUSIONS: This retrospective case series provides descriptive data on the safety of acupuncture using Japanese J-type Seirin needles, with mild manual stimulation administered at 0.5-cun depth in patients with cancer with and without thrombocytopenia. Prospective trials are needed to confirm these initial observations.

Global Use of Traditional and Complementary Medicine in Childhood Cancer: A Systematic Review.

Purpose Traditional and complementary medicine (T&CM) strategies are commonly used in pediatric oncology. Patterns may vary based on country income. We systematically reviewed published studies describing T&CM use among pediatric oncology patients in low-income countries (LIC/LMIC), middle-income countries (UMIC), and high-income countries (HIC). Objectives included describing estimated prevalence of use, reasons for use, perceived effectiveness, modalities used, rates of disclosure, and reporting of delayed or abandoned treatment. Methods MEDLINE, EMBASE, Global Health, CINAHL, PsycINFO, Allied and Complementary Medicine Database, Cochrane Database of Systematic Reviews, and ProceedingsFirst were searched. Inclusion criteria were primary studies involving children younger than the age of 18 years, undergoing active treatment of cancer, and any T&CM use. Exclusion criteria included no pediatric oncology-specific outcomes and studies involving only children off active treatment. Data were extracted by two reviewers using a systematic data extraction form determined a priori. Results Sixty-five studies published between 1977 and 2015 were included, representing 61 unique data sets and 7,219 children from 34 countries. The prevalence of T&CM use ranged from 6% to 100%. Median rates of use were significantly different in LIC/LMIC (66.7% ± 19%), UMIC (60% ± 26%), and HIC (47.2% ± 20%; P = .02). Rates of disclosure differed significantly by country income, with higher median rates in HIC. Seven studies reported on treatment abandonment or delays. Conclusion The use of T&CM in pediatric oncology is common worldwide, with higher median prevalence of use reported in LIC/LMIC. Further research is warranted to examine the impact on treatment abandonment and delay.