Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study.

PURPOSE: Successful completion of chemotherapy is critical to improve breast cancer outcomes. Relative dose intensity (RDI), defined as the ratio of chemotherapy delivered to prescribed, is a measure of chemotherapy completion and is associated with cancer mortality. The effect of exercise and eating a healthy diet on RDI is unknown. We conducted a randomized trial of an exercise and nutrition intervention on RDI and pathologic complete response (pCR) in women diagnosed with breast cancer initiating chemotherapy. METHODS: One hundred seventy-three women with stage I-III breast cancer were randomly assigned to usual care (UC; n = 86) or a home-based exercise and nutrition intervention with counseling sessions delivered by oncology-certified registered dietitians (n = 87). Chemotherapy dose adjustments and delays and pCR were abstracted from electronic medical records. T-tests and chi-square tests were used to examine the effect of the intervention versus UC on RDI and pCR. RESULTS: Participants randomly assigned to intervention had greater improvements in exercise and diet quality compared with UC (P < .05). RDI was 92.9% ± 12.1% and 93.6% ± 11.1% for intervention and UC, respectively (P = .69); the proportion of patients in the intervention versus UC who achieved ≥85% RDI was 81% and 85%, respectively (P = .44). The proportion of patients who had at least one dose reduction and/or delay was 38% intervention and 36% UC (P = .80). Among 72 women who received neoadjuvant chemotherapy, women randomly assigned to intervention were more likely to have a pCR than those randomly assigned to UC (53% v 28%; P = .037). CONCLUSION: Although a diet and exercise intervention did not affect RDI, the intervention was associated with a higher pCR in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative and triple-negative breast cancer undergoing neoadjuvant chemotherapy.

Virtual acupressure for symptom management in cancer populations during COVID-19: a retrospective analysis.

OBJECTIVE: Following the outbreak of COVID-19, access to in-person oncology acupuncture service was temporarily disrupted at Dana-Farber Cancer Institute, a National Cancer Institute (NCI)-designated cancer center. During this period, a virtual acupuncturist-guided session of patient self-acupressure was implemented to provide continuity of supportive care for cancer patients. We provide preliminary findings on the feasibility and potential impact of remotely delivered acupressure on patient-reported symptom burden in cancer populations. METHODS: This is a retrospective chart review of cancer patients who received virtual acupressure service at a single academic cancer center from May 11 to December 31, 2020. Each telehealth session consisted of a one-on-one appointment between the patient and acupuncturist. A semi-standardized set of acupoints were used, including Yintang, ST36, GB20, PC6, and HT7 as well as Relaxation Point on the ear. At the start of each session, Edmonton Symptom Assessment System (ESAS) was used to collect patient-reported symptom burden. For patients with at least one follow-up within 14 days of the baseline visit, paired t-test was used to analyze changes in ESAS scores from baseline to first follow-up. RESULTS: A total of 102 virtual acupressure sessions were administered to 32 patients. Most patients were females (90.6%) and white (84.4%), and the mean age was 55.7 (range = 26-82; SD = 15.7). The most common cancer diagnosis was breast (53.1%), followed by pancreatic (12.5%) and lung (9.4%). Baseline ESAS Total, Physical, and Emotional scores were 21.5 (SD = 11.1), 12.4 (SD = 7.5), and 5.2 (SD = 3.8), respectively. Of 32 patients, 13 (41%) had a second acupressure session within 14 days. For these 13 patients, there was a statistically significant reduction in Total symptom burden (-4.9 ± 7.6; p = 0.04) and in Physical (-3.5 ± 5.4; p = 0.04) and Emotional (-1.2 ± 1.8; p = 0.03) subscales from baseline to follow-up. CONCLUSION: Virtual acupressure was associated with significant reduction in symptom burden among cancer patients from their baseline to follow-up visits. Larger scale randomized clinical studies are needed to confirm these findings and better understand the impact of virtual acupressure on symptom burden in cancer populations.

Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol.

BACKGROUND: Acupuncture has been reported to reduce hot flashes in patients with breast cancer undergoing adjuvant hormonal therapy. Although hot flashes are common, the prevalence varies among cultures, races, and ethnicities; the efficacy of acupuncture across cultures has not been investigated. METHODS: This is a coordinated multinational study, including three parallel randomized trials with a planned analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients on adjuvant endocrine therapy. Using a standardized acupuncture protocol (total across all three studies of n = 80) versus usual care (total n = 80), symptoms are assessed using changes in the Endocrine Symptom Subscale of Functional Assessment of Cancer Therapy-Endocrine Symptoms. Secondary outcomes include hot flash severity, quality of life, and sleep quality. Differences in response to acupuncture between participants in the three countries will also be explored. DISCUSSION: Here we describe the design of a protocol for a coordinated multinational study, with attention to the complex considerations in developing a multinational research effort testing a non-pharmacologic intervention. This protocol and approach provide guidance for future efforts to evaluate and test non-pharmacologic interventions across multinational populations. TRIAL REGISTRATION: clinicaltrials.gov (Identifier: NCT00797732, registered on December 21, 2018), Chinese Clinical Trial Registry (ChiCTR2100045888), and The Clinical Research Information Service (CRIS) of Korea (Registration number: KCT0003618).

Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic.

The outbreak of the coronavirus disease 2019 (COVID-19) and subsequent need for disease transmission mitigation efforts have significantly altered the delivery of cancer care (e.g., rise of telemedicine), including within the field of integrative oncology. However, little has been described about how National Cancer Institute-Designated Cancer Centers have transformed integrative oncology care delivery in response to the COVID-19 pandemic. The purpose of this commentary is to describe the delivery of integrative oncology clinical services and conduct of research at The Leonard P. Zakim Center for Integrative Therapies and Healthy Living at Dana-Farber Cancer Institute during the COVID-19 pandemic. Clinical services transitioned from an array of in-person appointment-based services, such as acupuncture and massage, and group programs, such as yoga and nutrition seminars to a combination of live-streamed and on-demand virtual group programs and one-on-one virtual appointments for services such as acupressure and self-care massage. Group program volume grew from 2189 in-person program patient visits in the 6 months prior to onset of the COVID pandemic to 16,366 virtual (e.g., live-streamed or on-demand) patient visits in the first 6 months of the pandemic. From a research perspective, two integrative oncology studies, focused on yoga and music therapy, respectively, were transitioned from in-person delivery to a virtual format. Participant accrual to these studies increased after the transition to virtual consent and intervention delivery. Overall, our clinical and research observations at Dana-Farber Cancer Institute suggest that the delivery of virtual integrative oncology treatments is feasible and appealing to patients. Trial Registration: NCT03824860 (Yoga); NCT03709225 (Music Therapy).

Consensus minimum hemoglobin level above which patients with myelodysplastic syndromes can safely forgo transfusions.

The anemia of MDS often results in decreased quality of life, which is invoked to justify red cell transfusions; however, there are sparse data regarding the minimum hemoglobin (Hb) at which it is safe to forgo transfusions for patients with no evidence of end-organ damage. This issue is even more important in the COVID-19 era, where decreases in blood donations have stressed the blood supply. In March 2018, using a modified Delphi method, we convened a panel of 13 expert MDS clinicians for three iterative rounds to discuss a minimum safe Hb for this population. While the panel was unable to reach the pre-set consensus of 75% for a specific Hb threshold, there was 100% consensus that it be no greater than 7.5 g/dL. Our data suggest that, given no end-organ effects of anemia, patients with MDS can safely forgo transfusions with a Hb of 7.5 g/dL or higher.

Performance of the International Myeloma Working Group myeloma frailty score among patients 75 and older.

OBJECTIVES: We compared the performance of two frailty scoring systems in predicting survival among older patients with multiple myeloma: the International Myeloma Working Group (IMWG) frailty score (which includes age), and the Fried model for frailty (which does not). METHODS: From 2015 to 2018, all patients aged 75 years and older presenting at our institution with a diagnosis of multiple myeloma were approached for a frailty screening assessment. We first categorized patients' frailty using the Fried model. Then, using available deficit measures, we reclassified frailty using the IMWG approach. We compared the performance of the IMWG strategy to the Fried model in terms of association with overall survival. RESULTS: Of the 98 (92%) patients who consented to a baseline frailty assessment, we found 57% discordance among frailty classification between the two scoring systems. Using the IMWG strategy, 9% of the cohort was "fit," 29% "intermediate-fit," and 62% "frail." Using the Fried model, 29% of the cohort was "robust," 52% "pre-frail," and 19% "frail." Frailty category in the Fried model was predictive of overall survival among our cohort, while frailty category in the IMWG strategy was not (log-rank p = 0.04 vs. 0.34). CONCLUSION: Among our cohort of older patients with myeloma (aged 75 and higher), the Fried model appears to be a better predictor of survival compared to the IMWG strategy. These results suggest that using age as a criterion to identify frailty in older patients with multiple myeloma may limit treatment options for the functionally vigorous.