Exercise for Breast Cancer Survivors

Overseen By Christina M Dieli-Conwright, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific exercise routine can boost fitness and lower the risks of heart disease, diabetes, and obesity for Latina women who have survived breast cancer. Participants will either engage in a structured exercise program called Progressive Combine Training (PCT) or a home-based stretching routine. Latina women in breast cancer remission who completed treatment like chemotherapy or radiation in the past year might be a good fit, especially if they currently do less than an hour of structured exercise per week. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve health outcomes for 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that exercise, including programs like Progressive Combine Training (PCT), is generally safe for breast cancer survivors. Studies have found that resistance training, a component of PCT, is well-tolerated and can boost muscle strength without causing harm. Additionally, combining strength and aerobic exercises, as done in PCT, effectively improves body shape and overall fitness.

Breast cancer survivors have safely used exercise programs like PCT to help reduce treatment side effects, such as muscle loss. No major reports of serious problems have been linked to these exercise routines. This suggests that PCT could be a safe way to improve fitness for Latina breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Progressive Combine Training (PCT) for breast cancer survivors because it introduces a structured, two-phase exercise regimen that combines both resistance and cardiovascular training. Unlike standard post-treatment recommendations, which often focus on general physical activity, PCT provides a progressive and supervised approach initially, followed by an unsupervised phase, potentially enhancing long-term fitness habits. This method aims to improve overall health and recovery in a more targeted manner, possibly leading to better physical and psychological outcomes for survivors.

What evidence suggests that this trial's treatments could be effective for improving fitness and reducing heart disease, diabetes, and obesity risk factors in Latina breast cancer survivors?

Research has shown that combining aerobic exercises, such as jogging, with strength training can improve health in breast cancer survivors. Studies indicate that this exercise regimen helps reduce tiredness, improve sleep, and enhance overall quality of life. It also aids in weight management and increases muscle strength. Although the effects on inflammation remain unclear, strong evidence supports its benefits for heart health and fitness. In this trial, participants in the Progressive Combine Training (PCT) arm will engage in these exercises, potentially reducing the risks of heart disease, diabetes, and obesity in Latina breast cancer survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control (AC)
• Progressive Combine Training (PCT)

Trial Overview

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.

How Is the Trial Designed?

Group I: Progressive combine training (PCT) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

The Strength after Breast Cancer (SABC) program was successfully implemented in outpatient rehabilitation clinics, with 76% of surveyed clinicians adopting it and 93% continuing to deliver the program, indicating strong sustainability.

The program reached an average of 13 patients per clinic, primarily through referrals from oncology clinics, although barriers such as lack of referrals and competing clinic demands were noted, highlighting areas for improvement in implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Strength after Breast Cancer (SABC) in outpatient rehabilitation clinics: mapping clinician survey data onto key implementation outcomes. Calo, WA., Doerksen, SE., Spanos, K., et al.[2022]

Progressive resistance training (PRT) significantly reduces the risk of breast cancer-related lymphedema (BCRL) and does not worsen arm volume or symptom severity, based on a review of 15 randomized controlled trials involving 1,652 patients.

PRT also leads to significant improvements in upper and lower body muscular strength, although it does not have a notable impact on health-related quality of life, suggesting that PRT is beneficial for physical functioning in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of progressive resistance training in breast cancer: a systematic review and meta-analysis. Cheema, BS., Kilbreath, SL., Fahey, PP., et al.[2022]

Regular moderate exercise significantly enhances physical, mental, and social well-being in breast cancer survivors after treatment, promoting overall recovery and quality of life.

A supportive environment and positive mindset towards exercise are crucial for encouraging breast cancer survivors to adopt and maintain an active lifestyle, which can improve their physical strength and endurance post-therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing exercise in breast cancer survivors. Adkins, BW.[2009]

Exercise significantly benefits breast cancer survivors, with recommendations for moderate-intensity aerobic activity 3 to 5 days a week for 20 to 60 minutes, along with resistance training.

Psychological health improves with enjoyable exercise that includes social interaction and skill development, while modifications may be needed for conditions like fatigue or lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. Courneya, KS., Mackey, JR., McKenzie, DC.[2010]

A systematic review of 10 trials, including 5 randomized controlled trials, indicates that progressive resistance training (PRT) is safe and does not worsen lymphedema symptoms in women after breast cancer surgery.

PRT appears to provide health-related benefits for breast cancer survivors, suggesting it could be an effective part of post-surgery rehabilitation, although more robust studies are needed to confirm its efficacy and promote its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive resistance training in breast cancer: a systematic review of clinical trials. Cheema, B., Gaul, CA., Lane, K., et al.[2022]

The STRENGTH trial involving 90 premenopausal breast cancer patients on chemotherapy demonstrated that home-based diet and exercise interventions can help prevent weight gain and preserve lean body mass during treatment.

The combination of a calcium-rich diet, exercise, and a high fruit and vegetable, low-fat diet led to a significant reduction in body fat percentage compared to the control group, highlighting the potential for dietary and exercise strategies to improve body composition in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. Demark-Wahnefried, W., Case, LD., Blackwell, K., et al.[2021]

The ABRACE Study will evaluate the effects of different volumes of resistance training combined with aerobic exercise on physical and psychological outcomes in 84 breast cancer patients undergoing chemotherapy, aiming to clarify optimal exercise prescriptions during treatment.

The study hypothesizes that both resistance training groups (single and multiple sets) will show superior improvements in neuromuscular function and quality of life compared to a control group, potentially establishing exercise as a key management strategy for treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial. Henkin, JS., Rosa, DD., Morelle, AM., et al.[2023]

Exercise training is a safe and well-tolerated adjunct therapy for cancer patients, showing potential to reduce treatment-related side effects during and after adjuvant therapy.

Current evidence suggests that incorporating exercise into the care plan for cancer survivors may enhance their overall management, although further research is needed to fully understand its benefits across different stages of cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy in the management of solid tumors. Jones, LW., Peppercom, J., Scott, JM., et al.[2021]

In a study of 27 breast cancer survivors over six months, resistance training significantly improved objective measures of muscular strength and physical function, indicating its potential benefits for recovery post-treatment.

Despite the improvements in physical strength and function, no changes were observed in subjective measures of quality of life, suggesting that further research is needed to understand the full impact of resistance training on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Resistance Training on Physical Function and Quality of Life in Breast Cancer Survivors. Simonavice, E., Liu, PY., Ilich, JZ., et al.[2020]

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