Exercise for Breast Cancer Survivors
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dana-Farber Cancer Institute
Must be taking: Adjuvant endocrine
Must not be taking: Metformin, Investigational agents
Disqualifiers: Uncontrolled illness, Active malignancies, Metastatic disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you may continue using adjuvant endocrine therapy if it will be used for the duration of the study.
What data supports the effectiveness of this treatment for breast cancer survivors?
Research shows that progressive resistance training (a type of exercise that gradually increases the resistance or weight used) can help breast cancer survivors improve their physical function and quality of life after treatment. Exercise therapy, in general, is considered safe and can reduce common side effects of cancer treatment, making it a valuable part of recovery.
12345Is exercise safe for breast cancer survivors?
Research shows that progressive resistance training is generally safe for breast cancer survivors. It does not worsen arm swelling or symptoms and can improve muscle strength.
13678How is the treatment Progressive Combine Training (PCT) unique for breast cancer survivors?
Progressive Combine Training (PCT) is unique because it includes progressive resistance training, which helps improve muscle strength and reduce the risk of lymphedema (swelling due to lymph fluid buildup) without worsening symptoms. This approach is different from standard aerobic exercises, as it specifically targets muscle building and physical functioning, which are crucial for breast cancer survivors.
13789Eligibility Criteria
This trial is for Latina breast cancer survivors who are obese, have completed their main cancer treatments within the last year, and currently exercise less than 60 minutes a week. They must not smoke, be free from serious chronic diseases, agree to use contraception if applicable, and be willing to travel for the study.Inclusion Criteria
You consider yourself as Latina.
Does not smoke (no smoking during previous 12 months)
I agree to use effective birth control or abstain from sex for six months during the study.
+15 more
Exclusion Criteria
I haven't finished any surgery, chemotherapy, or radiation for my diagnosis.
I cannot travel to the specified hospital or exercise facility for data collection.
I do not have any uncontrolled illnesses or infections, and if I'm a woman with diabetes, I'm not using Metformin.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Testing
Participants undergo two baseline tests before starting the program
1-2 weeks
Phase 1 Treatment
Supervised 16-week resistance and cardiovascular exercise at a local YMCA or remotely at home via Zoom
16 weeks
Midpoint testing at approximately week 8
Phase 2 Treatment
Unsupervised 16-week resistance and cardiovascular exercise at a local YMCA or remotely at home with weekly check-ins
16 weeks
Midpoint testing approximately two months into phase 2
Attention Control
12 months of home-based stretching with periodic testing
12 months
Testing during months 2, 4, 6, 8, 10, and two tests in month 12
Follow-up
Participants are monitored for changes in metabolic dysregulation during a 4-month follow-up period
4 months
Participant Groups
The study tests whether Progressive Combined Training (PCT), an exercise program, can improve fitness and reduce heart disease, diabetes, and obesity risks compared to standard care (Attention Control) in participants.
2Treatment groups
Experimental Treatment
Active Control
Group I: Progressive combine training (PCT)Experimental Treatment1 Intervention
Participants will be randomly assigned to Progressive combine training (PCT) group.
Participants will have two (2) baseline tests, then begin a two phase PCT program.
* Phase 1: Supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom
* Participants will receive midpoint testing, approximately week 8.
* Phase 2: Unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home
* Participants will receive midpoint testing, approximately two months into phase 2.
After the two (2) 16-week phases, participants will be followed for 4 months.
Group II: Attention Control (AC)Active Control1 Intervention
Participants will be randomly assigned to Attention Control (AC) group.
Two (2) baseline tests will be performed prior to starting the program. Participants will perform 12 months of home-based stretching and have a 1x test performed during months 2, 4, 6, 8 and 10. Two (2) tests will be performed in month 12.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
American Cancer Society, Inc.Collaborator
References
Progressive resistance training in breast cancer: a systematic review of clinical trials. [2022]Progressive resistance training (PRT) may be effective for targeting the sequelae of breast cancer and its treatment given the unique anabolic nature of this exercise modality. Therefore, our objectives were: (1) to systematically review studies that have prescribed PRT after breast cancer surgery, (2) to summarize the efficacy of PRT in this cohort, and (3) to delineate areas for future investigations.
Exercise therapy in the management of solid tumors. [2021]OPThe benefits of exercise in patients with chronic disease have been studied extensively over the last half century. In contrast, investigation of the role of exercise following a diagnosis of cancer has received comparably less attention. In this article, we review the efficacy of exercise training in specific areas across the cancer survivorship continuum [i.e., pre-surgery, post-surgery during adjuvant therapy, following the completion of primary adjuvant therapy (survivorship), and palliation], with a view toward future research. The current evidence base provides strong but preliminary evidence that exercise training is a well-tolerated and safe adjunct therapy that can mitigate several common treatment-related side-effects among cancer patients with early disease both during and following adjuvant therapy although many questions remain unanswered. Preliminary evidence in this area supports that exercise therapy may be an important consideration in multidisciplinary management of patients following a cancer diagnosis.
Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. [2021]Patients with breast cancer on adjuvant chemotherapy can experience weight gain and concurrent losses in muscle mass. Exercise interventions can prevent these changes, but time and travel pose barriers to participation. The Survivor Training for Enhancing Total Health (STRENGTH) trial assessed the feasibility and impact of 2 home-based interventions.
Implementing Strength after Breast Cancer (SABC) in outpatient rehabilitation clinics: mapping clinician survey data onto key implementation outcomes. [2022]While 3.5 million breast cancer survivors in the USA are indicative of promising disease-free survival, many experience adverse effects in recovering from treatment. Evidence-based exercise programs may be a low-cost, easily disseminable solution to the challenge of recovering from adverse treatment affects. Therefore, after establishing efficacy in a large randomized controlled trial, we developed the Strength after Breast Cancer (SABC) program and the accompanying online course for clinicians interested in physical therapy to learn to deliver this rehabilitative exercise program to individuals with breast cancer. We surveyed clinicians who took the course to assess implementation of the program in outpatient rehabilitation clinics.
The Effects of Resistance Training on Physical Function and Quality of Life in Breast Cancer Survivors. [2020]Breast cancer survivors (BCS) exhibit decreased physical function and quality of life (QOL) following cancer treatments. Resistance training (RT) may elicit positive changes in physical and mental well-being. This study assessed 27 BCS, pre-and post-intervention (six months) on the following variables: muscular strength (via one repetition maximum (1RM) of chest press and leg extension), physical function (via the Continuous Scale-Physical Functional Performance test) and QOL (via the Short Form-36 survey). RT consisted of two days/week of ten exercises including two sets of 8-12 repetitions at 52%-69% of their 1RM. A repeated measures analysis of variance revealed BCS significantly (p
Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial. [2023]An increased number of breast cancer patients are challenged by acute and persistent treatment side effects. Oncology guidelines have been establishing physical exercise to counteract several treatment-related toxicities throughout cancer care. However, evidence regarding the optimal dose-response, feasibility, and the minimal resistance exercise volume and/or intensity remains unclear. The ABRACE Study will assess the impact of different resistance training volumes (i.e., single or multiple sets) combined with aerobic exercise on physical and psychological outcomes of breast cancer patients undergoing primary treatment.
Safety and efficacy of progressive resistance training in breast cancer: a systematic review and meta-analysis. [2022]The purpose of this study was to assess the safety and efficacy of progressive resistance training (PRT) in breast cancer. Randomized controlled trials (RCTs) published to November 2013 that reported on the effects of PRT (>6 weeks) on breast cancer-related lymphedema (BCRL) (incidence/exacerbation, arm volume, and symptom severity), physical functioning (upper and lower body muscular strength), and health-related quality of life (HRQoL) in breast cancer patients were included. Of 446 citations retrieved, 15 RCTs in 1,652 patients were included and yielded five studies on BCRL incidence/exacerbation (N = 647), four studies on arm volume (N = 384) and BCRL symptom severity (N = 479), 11 studies on upper body muscular strength (N = 1,252), nine studies on lower body muscular strength (N = 1,079), and seven studies on HRQoL (N = 823). PRT reduced the risk of BCRL versus control conditions [OR = 0.53 (95% CI 0.31-0.90); I2 = 0%] and did not worsen arm volume or symptom severity (both SMD = -0.07). PRT significantly improved upper [SMD = 0.57 (95% CI 0.37-0.76); I2 = 58.4%] and lower body muscular strength [SMD = 0.48 (95% CI 0.30-0.67); I2 = 46.7%] but not HRQoL [SMD = 0.17 (95% CI -0.03 to 0.38); I2 = 47.0%]. The effect of PRT on HRQoL became significant in our sensitivity analysis when two studies conducted during adjuvant chemotherapy [SMD = 0.30 (95% CI 0.04-0.55), I2 = 37.0%] were excluded. These data indicate that PRT improves physical functioning and reduces the risk of BCRL. Clinical practice guidelines should be updated to inform clinicians on the benefits of PRT in this cohort.
Exercise for breast cancer survivors: research evidence and clinical guidelines. [2010]Exercise can have significant benefits for breast cancer survivors during and after treatment. The general aerobic prescription is for moderate-intensity activity (50% to 75% heart rate reserve), 3 to 5 days per week, 20 to 60 minutes per session. Resistance training should also be incorporated into the programs. Psychological health is optimized by exercise that is enjoyable, develops new skills, incorporates social interaction, and takes place in a mind- and spirit-stimulating environment. Conditions that warrant prescription modification include fatigue and nausea, cytopenias, lymphedema, and bone metastasis. Postcancer exercise is facilitated by instilling a positive attitude toward exercise, confidence in overcoming barriers, and a supportive social environment.
Maximizing exercise in breast cancer survivors. [2009]Regular physical exercise can maximize physical, mental, and social well-being during and after treatment in breast cancer survivors. An exercise program following cancer therapy is facilitated by instilling a positive attitude toward exercise, confidence in conquering barriers, and a supportive social environment. The purpose of this article is to describe the benefits of moderate exercise in breast cancer survivors and propose a comprehensive approach for the cancer care team in maximizing survivor efforts to improve their physical strength and endurance after completion of adjuvant therapy for breast cancer (surgery, chemotherapy, and/or radiation). A moderate exercise program can help most survivors become more physically and mentally fit and energetic. Understanding factors that prompt the initiation of healthy lifestyle choices among breast cancer survivors is critical to encouraging an attitude of healthy living.