Exercise Intervention for Metastatic Breast Cancer
Palo Alto (17 mi)Overseen byTarah Ballinger, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Indiana University
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to study exercise in a novel population with indolent MBC (no progression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensity aerobic and resistance training exercise for 16 weeks in this population will significantly improve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass), all established predictors of survival, and 2) patient- reported outcomes.
Is exercise a promising treatment for metastatic breast cancer?Yes, exercise is a promising treatment for metastatic breast cancer. Studies show that exercise can improve fitness, functional capacity, and quality of life for patients. It is considered feasible and safe, and patients have positive perspectives on participating in exercise programs.4571011
What safety data exists for exercise interventions in metastatic breast cancer?The safety of exercise interventions, including aerobic and resistance training, in metastatic breast cancer has been evaluated in several studies. A randomized controlled trial specifically focused on aerobic training in metastatic breast cancer patients found it to be feasible and safe. Additionally, a systematic review and meta-analysis of exercise therapy in cancer patients reported that 63% of trials monitored adverse events, with a total of 44 adverse events reported across 48 trials. These findings suggest that exercise interventions are generally safe for cancer patients, including those with metastatic breast cancer.23569
What data supports the idea that Exercise Intervention for Metastatic Breast Cancer is an effective treatment?The available research shows that exercise interventions can improve fitness, physical performance, and quality of life for patients with metastatic breast cancer. For example, a case study of a patient with advanced breast cancer and bone metastases who participated in an aerobic exercise program showed significant improvements in physical performance and quality of life over a year. Additionally, a literature review suggests that physical activity can be a valuable part of cancer care, improving outcomes for patients undergoing treatment for metastatic disease. However, the research also notes that exercise programs should be tailored to individual needs and conditions.145811
Do I have to stop taking my current medications for the trial?The trial does not specify that you need to stop taking your current medications. Participants receiving endocrine therapy, targeted therapy, or antibody therapy are eligible, but those receiving cytotoxic chemotherapy in the past 12 months are not eligible.
Eligibility Criteria
This trial is for adults over 18 with metastatic breast cancer who haven't seen their disease progress in the last year. They should not be currently meeting exercise guidelines and must be able to march in place for half a minute. People with recent heart attacks, uncontrolled heart failure or asthma, severe comorbidities, upcoming orthopedic surgery, active brain metastases, or those on cytotoxic chemotherapy within the past year can't join.Inclusion Criteria
I can take care of myself and am up and about more than half of my waking hours.
I have metastatic breast cancer but am currently not on treatment or show no signs of the disease.
My condition has not worsened in the past year.
I am 18 years old or older.
My breast cancer has spread to other parts of my body.
I can march in place for 30 seconds, with support if needed.
Exclusion Criteria
I have symptoms of poor blood flow in my limbs.
I have chest pain that isn't managed by medication.
I have severe heart failure.
I have severe lung problems needing oxygen or have asthma symptoms more than twice a week.
I have had a heart attack in the last year.
I have not had orthopedic surgery in the last 3 months and do not plan to during the study.
I have brain metastases that haven't been treated.
I have had chemotherapy in the last year.
Treatment Details
The EMBody trial tests a virtual exercise program combining aerobic and resistance training over 16 weeks for people with stable metastatic breast cancer. The goal is to see if this improves fitness levels, muscle mass (sarcopenia), functional status—all linked to survival—and patient-reported outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise InterventionExperimental Treatment1 Intervention
Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.
Group II: Usual CareActive Control1 Intervention
Participants randomized to usual care (UC) will receive care per their treatment team. UC participants are encouraged to exercise but will not be provided components of the intervention. Participants in the UC arm will be given usual care handouts at baseline from the American College of Sports Medicine.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Sidney and Lois Eskenazi HospitalIndianapolis, IN
IU Health Joe and Shelly Schwarz Cancer CenterCarmel, IN
Indiana University Melvin & Bren Simon Cancer CenterIndianapolis, IN
IU Health WestAvon, IN
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
References
Aerobic exercise for a patient suffering from metastatic bone disease. [2004]A 48-year-old female patient suffering from advanced breast cancer with metastatic bone disease participated in an aerobic exercise program consisting of ergometer cycling three times a week for 1 year. Feasibility, safety and beneficial effects of the program were proven for the patient in this case study. VO(2)max (20.2% after 16 weeks, 52.7% after 12 months) and peak work capacity (15.5% after 16 weeks, 35.7% after 12 months) had increased. The patient experienced a marked improvement in physical performance and in quality of life. Aerobic exercise, initiated and executed with appropriate care, may serve as a useful additional means of palliative treatment in some cancer patients with bone metastases.
Effect of a vigorous aerobic regimen on physical performance in breast cancer patients - a randomized controlled pilot trial. [2022]This randomized, controlled pilot trial was carried out to assess the feasibility and efficacy of an aerobic exercise in enhancing physical performance of breast cancer patients after adjuvant treatments. The potential of the training regimen to prevent accompanying bone loss was also assessed. Thirty patients, 41-65 years of age, were randomly assigned into training or control groups shortly after adjuvant chemo- or radiotherapy. The 12-week training included a guided aerobic exercise session once a week (the effective part being either step aerobic- or circuit-training in alternate weeks) and similar home exercise sessions twice a week. Adherence to the guided sessions was 78%, while home training was performed an average 2.1 times per week. Agility assessed with figure-8 running test and peak jumping power showed significant between-group treatment-effects (approximately 5% and approximately 10%, respectively). Judged from the accelerometer data, reaction forces up to six times body weight occurred during the training, which implies that the training could also have potential to affect bone mass. The present exercise regimen turned out to be feasible and effective among breast cancer patients in terms of physical performance. Large controlled trials are necessary to confirm these findings.
Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]To evaluate the safety and efficacy of moderate-to-high intensity aerobic training in breast cancer patients receiving neoadjuvant chemotherapy.
Randomized trial of a physical activity intervention in women with metastatic breast cancer. [2016]Exercise interventions improve fitness, functional capacity, and quality of life in patients with early-stage breast cancer, but to the authors' knowledge there are few data regarding the feasibility or potential benefits of exercise in women with metastatic breast cancer.
Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. [2023]The investigation of exercise training in metastatic breast cancer has received minimal attention. This study determined the feasibility and safety of aerobic training in metastatic breast cancer.
Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]Purpose To evaluate the effects of exercise therapy on cardiorespiratory fitness (CRF) in randomized controlled trials (RCTs) among patients with adult-onset cancer. Secondary objectives were to evaluate treatment effect modifiers, safety, and fidelity. Methods A systematic search of PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Library was conducted to identify RCTs that compared exercise therapy to a nonexercise control group. The primary end point was change in CRF as evaluated by peak oxygen consumption (VO2peak; in mL O2 × kg-1 × min-1) from baseline to postintervention. Subgroup analyses evaluated whether treatment effects differed as a function of exercise prescription (ie, modality, schedule, length, supervision), study characteristics (ie, intervention timing, primary cancer site), and publication year. Safety was defined as report of any adverse event (AE); fidelity was evaluated by rates of attendance, adherence, and loss to follow-up. Results Forty-eight unique RCTs that represented 3,632 patients (mean standard deviation age, 55 ± 7.5 years; 68% women); 1,990 (55%) and 1,642 (45%) allocated to exercise therapy and control/usual care groups, respectively, were evaluated. Exercise therapy was associated with a significant increase in CRF (+2.80 mL O2 × kg-1 × min-1) compared with no change (+0.02 mL O2 × kg-1 × min-1) in the control group (weighted mean differences, +2.13 mL O2 × kg-1 × min-1; 95% CI, 1.58 to 2.67; I2, 20.6; P < .001). No statistical significant differences were observed on the basis of any treatment effect modifiers. Thirty trials (63%) monitored AEs; a total of 44 AEs were reported. The mean standard deviation loss to follow-up, attendance, and adherence rates were 11% ± 13%, 84% ± 12%, and 88% ± 32%, respectively. Conclusion Exercise therapy is an effective adjunctive therapy to improve CRF in patients with cancer. Our findings support the recommendation of exercise therapy for patients with adult-onset cancer.
Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study. [2021]There is limited knowledge regarding the potential benefits of physical activity in patients with metastatic breast cancer.
Exercise interventions in metastatic cancer disease: a literature review and a brief discussion on current and future perspectives. [2021]Exercise is a well-established factor which improves outcomes of oncological patients during curative treatment as well as in cancer survivors. However, the role of physical activity in metastatic disease, due to the deficiency of high-level evidence from prospective clinical trials, remains a partially unexplored field of research. Additionally, no specific guidelines related to exercise for persons with advanced cancer have been developed so far. Unfortunately, this research deficit may effectively prevent physicians from prescribing adequate and safe recommendations on physical activity to their patients. In an attempt to fill this gap in clinical practice, we present here an up-to-date review of potential benefits of exercise interventions in relation to the survival, quality of life and supportive care for patients with metastatic cancer. We also review the data on the safety of physical activity with special emphasis on elderly populations or individuals with bone metastases. Finally, we discuss the most relevant clinical factors that should be considered during exercise qualification. In conclusion, physical activity is an important tool for improving the outcomes of people undergoing anticancer therapy for metastatic disease. However, the training should be tailored individually to the patient's functional status, comorbidities and preferences. Physical activity should become a standard component of every metastatic cancer care plan.
Quantity of Resistance Exercise for Breast Cancer Patients: Does the Dose Match the Objective? [2023]Rosenberg, J, Hyde, PN, Yancy, WS, Ford, KM, and Champ, CE. Quantity of resistance exercise for breast cancer patients: does the dose match the objective? J Strength Cond Res 35(5): 1467-1476, 2021-There is currently a lack of consensus as to what defines exercise and resistance training in the cancer setting and whether current studies comply with exercise guidelines. This study aimed to quantify the available research studies using resistance training exercise interventions in the breast cancer setting for future clinical trial utilization. We systemically reviewed all available resistance exercise studies during and after breast cancer treatment in an attempt to quantify to the prescribed dose and whether regimens aligned with general exercise guidelines to improve functional mobility, body composition, and metabolic function. They were then compared with recommendations set forth by the national committees that create evidence-based exercise guidelines. Fifty studies met the initial criteria, with 35 meeting analysis criteria for evaluation. Fifteen studies evaluated an exercise regimen during cancer treatment, and 20 evaluated a regimen after treatment. The average adherence rates were 84% for all studies. Only 23 studies listed specific exercises used within the protocol. Most exercise regimens relied on open chain movements and machine exercises. Around half of studies met criteria to achieve hypertrophy, and 66% met American College of Sports Medicine exercise guidelines for cancer patients. A minority of breast cancer studies implementing a resistance training exercise regimen prescribed a regimen or specific dose that follows general exercise guidelines. This study highlights a potential deficiency in exercise programs designed for patients with breast cancer, and these findings should be considered in future study design.
Implementation of a Standard Care Program of Therapeutic Exercise in Metastatic Breast Cancer Patients. [2023]There is little information on the feasibility and benefit of therapeutic exercise (TE) in women with metastatic breast cancer (MBC). The aim of this article is to describe the implementation of a TE intervention in MBC patients, and to determine the recruitment, compliance and improvement in outcomes after its completion.
Perspectives of patients with metastatic breast cancer on physical exercise programs: results from a survey in five European countries. [2023]To successfully implement exercise programs for patients with metastatic breast cancer (MBC), services and patient education should consider patients' knowledge, preferences, values, and goals. Hence, gaining insight into their perspectives on exercise and exercise programming is important.