ABSTRACT
Background: Chemotherapy (CTX) for breast cancer (BC) can have a detrimental effect on cardiorespiratory fitness (CRF), as measured by VO2max. This decline may be attenuated by physical activity, which can also reduce mortality risk and improve quality of life (QoL) for patients (pts) with BC. During the COVID-19 pandemic, many have pivoted to home-based exercise routines, which have been shown to be safe and feasible for pts with BC receiving CTX. We conducted the STRENGTH Trial to evaluate the effect of a 12-week virtual supervised exercise program in BC pts receiving CTX on CRF. Method(s): This is a single-center, prospective, single-arm study designed to evaluate the effect of a 12-week virtual supervised exercise training program on CRF in BC pts receiving CTX. Participants aged >=18 years with stage I-IV BC who were planned to receive at least 12 weeks of CTX of investigator's choice were eligible for inclusion. Participants were asked to complete a total of 150 minutes (min) of moderate intensity physical activity/week, as a combination of a 45 min weekly virtual personal training session and workout classes streamed from the Peloton Digital platform (i.e. walking, running, cardio, yoga, strength training, and cycling). The primary endpoint was the distance walked on a Six-Minute Walk Test (6MWT), an accepted surrogate marker for VO2max, at the start and completion of the program. Secondary endpoints included assessment of QoL using the Functional Assessment of Cancer Therapy - General (FACT-G) and symptom assessment using the MD Anderson Symptom Inventory (MDASI) questionnaires at the beginning, middle and end of the study. Exploratory endpoints included treatment adherence, toxicities, completion and response. Result(s): 33 participants signed consent for the clinical trial and 2 withdrew voluntarily prior to beginning the program. 5 participants discontinued prematurely due to a diagnosis of COVID-19 (N=3) and pulmonary embolism (N=2) and were not included in the primary endpoint. One participant remains on study at this time. Median age 49 yrs;range 33-68. Mean BMI 29.55;range 18.1-46.5. 13 HR+/HER2-, 7 HR-/HER2-, 11 HER2+. 14 (45%) pts had Stage I, 11 (35%) pts had Stage 2, 5 (16%) pts had Stage 3, 1 (3%) pt had Stage 4. 23 pts (70%) received either an anthracycline or HER2-based therapy. 19 pts (61%) received neoadjuvant CTX on study, 11 pts (35%) received adjuvant CTX and 1 pt (3%) received treatment in metastatic setting. The average number of exercise min per week per participant was 123.2 min (95% CI, 104.1-142.2), with a relative dose intensity of 82%. In the pts that completed the study thus far (N=25), there was no statistically significant difference between the distance walked during the 6MWT at the start and end of the study (median difference= -10m, range: -129-150m, p= 0.67). There was no statistically significant difference in the FACT-G score at the start and end of the study (median difference= -1.0, range -17.83- 30.0, p=0.54). Pts scored higher on the MDASI (median difference= 0.33, range -1.55-4.62, p=0.04) at the end of the exercise program compared to the beginning. There were no new or unexpected treatment toxicities observed. Conclusion(s): Pts who participated in a 12-week virtual supervised exercise program during CTX for BC did not experience a statistically significant difference in the distance walked during the 6MWT between the beginning and end of the exercise program. Exercise may attenuate the decline in cardiorespiratory function that has historically been observed with CTX for BC. Some pts were not able to adhere to the recommended 150 min of exercise/week suggesting a potential need for modified exercise targets for pts with BC undergoing CTX. This study is limited by a small sample size and larger, randomized clinical trials are needed to further evaluate optimal exercise recommendations for patients with BC undergoing CTX in order to maintain and potentially, even improve, cardiorespiratory function.
ABSTRACT
Background: Nutrition and lifestyle interventions are instrumental in modifying cancer risk. These changes are often challenging for patients to make due to residual side effects from active treatment and/or ongoing toxicities from current treatment. The SHINE (Survivorship and Health Interventions in Nutrition and Exercise) Program is a wellness program for patients with breast cancer focusing on three pillars of nutrition, exercise and community in order to improve overall health outcomes and decrease the risk of cancer recurrence. Methods: Participants in SHINE have either been diagnosed with ductal carcinoma in situ (DCIS) and/or stage I-IV breast cancer. They are referred to the program at the threemonth breast surgery post-operative follow-up appointment or any time after that. All patients are referred to meet with a registered dietitian (RD) and integrative health coach, who provides counseling and education on how to reduce risk through diet and lifestyle, using evidence-based recommendations. Patients are provided with support and accountability. A collaborative program, the Physician Referred Exercise Program (PREP), was established with our health system's medical fitness center, Valley Health LifeStyles. Patients undergo a fitness assessment that focuses on aerobic fitness, muscle strength and endurance, flexibility, & functional activity. Each patient then receives an exercise prescription developed by a degreed exercise specialist, taking into account both the physician's & patient's recommendations & goals. Results: Each component of the SHINE Program has been developed in various stages due to the COVID-19 pandemic. 336 patients with either DCIS or stage I-IV breast cancer have been seen by the RD from December 2020 through January 2022. Mean number of visits/ patient: 1.89 (range 1-8). N = 48 were participants in a 12-week study on the feasibility of nutrition counseling and impact on quality of life (QOL) which is still in progress. 76 patient referrals have been placed to the PREP program from August 2021-February 2022. Multiple community programs (Table) have been created for patients to help them develop shared experiences & camaraderie with each other so that they can better integrate new ideas and lifestyle modifications. Conclusions: The SHINE Program addresses care for the whole person, empowering individuals to live their healthiest lifestyle. Future work will focus on clinical trials to evaluate the benefits of these individual and collective interventions on overall QOL, QOL subscales (physical, psychological, social & spiritual well-being), & survivorship symptoms.
ABSTRACT
Background: Chemotherapy for breast cancer can have a detrimental effect on cardiorespiratory fitness. VO2max (maximal oxygen consumption measured during exercise) is a key predictor of cardiovascular risk and has been found to be lower in women with a history of breast cancer compared with healthy women. Chemotherapy is associated with a decrease in VO2max but these decreases may be attenuated with exercise training, such as resistance, aerobic and high-intensity interval training programs. Physical activity may reduce the risk of mortality for breast cancer patients, improve quality of life (QoL) and reduce weight. All gyms and fitness studios had to close due to the COVID-19 pandemic, and while some have re-opened, many patients are not comfortable returning to an exercise facility now and are incorporating virtual exercise into their routine. Prior studies have demonstrated the safety, feasibility and potential benefits of home-based exercise programs for breast cancer patients receiving chemotherapy. However, many of these programs are self-reported, which can create bias and to our knowledge, there is no existing data on the effect of home-based exercise programs for breast cancer patients receiving neoadjuvant chemotherapy. The goal of the STRENGTH Trial is to evaluate the effect of a 12-week virtual supervised exercise program in breast cancer patients receiving chemotherapy on cardiorespiratory fitness. Study Description: This is a single-center, prospective, single-arm study designed to Sevaluate the effect of a virtual supervised exercise training program in breast cancer patients receiving chemotherapy on cardiorespiratory fitness. All participants are assigned to a 12-week virtual supervised exercise program and asked to complete a total of 150 minutes of moderate intensity physical activity per week, as a combination of a weekly virtual personal training sessionand workout classes streamed from the Peloton®Digital platform (i.e. walking, running, cardio, yoga, strength training, and cycling classes). Due to the ongoing COVID-19 pandemic, cardiorespiratory fitness cannot be assessed using a cardiopulmonary exercise test. As such, the co-primary endpoints are resting blood pressure and heart rate and distance walked during a Six-Minute Walk Test (6MWT), which is measured at the start and completion of the 12-week supervised exercise program. Secondary endpoints are QoL as assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) and symptom management assessment by the MD Anderson Symptom Inventory (MDASI). Several exploratory clinical endpoints will be collected including adherence to the program, type of fitness classes completed, and treatment toxicities. Eligibility Criteria: Patients aged ≥18 years with stage I to IV breast cancer who are planned to receive at least 12 weeks of chemotherapy of investigator's choice are eligible for inclusion. Patients who have an ejection fraction on echocardiogram <40%, symptomatic heart failure, myocarditis, myocardial infarction, cerebrovascular accident, pulmonary embolism or COVID-19 infection within past 3 months, severe, uncorrected valvular disease, uncontrolled hypertension and/or uncontrolled arrhythmias are excluded. Statistical Methods: Continuous and categorical variables measured in this study will be summarized. The distributions of the data collected in the study participants from the 6MWT, FACT-G and MDASI will be evaluated. Based upon the findings, either paired t-tests or nonparametric Wilcoxon signed-rank tests will be performed to analyze the differences observed between the pre-exercise intervention data and the post-exercise intervention data. P values <= 0.05 will be considered statistically significant. Accrual: At this time, 20 patients have enrolled out of a planned 30 participants.