Exercise for Breast Cancer

Not currently recruiting at 1 trial location

Overseen By Christina M Dieli-Conwright, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must not be taking: 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: 7

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a 16-week exercise program might reduce inflammation in fat tissue for women who have completed breast cancer treatment. Participants will join one of two groups: one will engage in traditional aerobic and resistance exercises, while the other will perform circuit-style exercises (referred to as CARE). The trial seeks women who have had breast cancer (but not stage IV), completed their treatment, are centrally obese (with a BMI over 30), and currently engage in less than 60 minutes of structured exercise per week.

As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of exercise after cancer treatment.

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 can continue using adjuvant endocrine therapy, trastuzumab, or pertuzumab if you will be on them for the duration of the study.

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

Studies have shown that both traditional and circuit-style aerobic resistance exercises are generally safe for breast cancer survivors. Research indicates that resistance exercise can strengthen women with breast cancer, even during treatment, without causing major negative effects. Aerobic training is also considered safe, though some patients might find it challenging to maintain the schedule. Overall, exercise is linked to better outcomes for breast cancer patients, including a reduced risk of recurrence.

For circuit-style aerobic resistance, research suggests it is safe and feasible for cancer survivors. It may also enhance bone health, which is crucial after cancer treatment. Overall, these exercises have been well-tolerated in studies and could offer additional health benefits, such as improved strength and bone health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise programs for breast cancer because they offer unique approaches compared to standard treatments like surgery, chemotherapy, and radiation. The CARE program incorporates circuit-style aerobic and resistance exercises, which may enhance physical fitness and potentially improve recovery and quality of life during and after cancer treatment. The Traditional Aerobic Resistance Exercise (TARE) provides a structured regimen combining both aerobic and resistance exercises, which could help maintain muscle mass and combat fatigue. These exercise-based treatments aim to empower patients with active roles in their recovery, offering a holistic complement to conventional medical therapies.

What evidence suggests that this trial's exercise programs could be effective for reducing inflammation in fat tissue for breast cancer survivors?

Research has shown that exercise can greatly benefit people with breast cancer. Studies have found that regular aerobic and strength exercises improve the quality of life and physical abilities of these patients. Exercise is also linked to lower chances of cancer recurrence and reduced death rates.

In this trial, participants will join different exercise programs. One group will engage in a 16-week circuit-style aerobic and resistance exercise program, which has improved muscle and heart health and reduced heart disease risks. Another group will participate in a traditional aerobic and resistance exercise program. Additionally, a home-based stretching program serves as an attention control. These exercise routines hold promise for improving health in those who have completed breast cancer treatment. ^{5 6 7 8 9}

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 women over 18 with breast cancer who've finished treatment, are in remission, and meet specific health criteria like a BMI >30. They must not have other uncontrolled illnesses or be on certain treatments. Participants should exercise less than 60 minutes per week and agree to use contraception.

Inclusion Criteria

I have had surgery to remove a breast lump or the entire breast.

I do not have chronic diseases like uncontrolled diabetes, high blood pressure, or thyroid issues.

My breast cancer is in remission with no signs of disease.

Exclusion Criteria

You are currently a smoker.

I am not currently on any experimental treatments or other cancer therapies.

You do more than 60 minutes of organized exercise every week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 16-week exercise program involving either circuit-style or traditional aerobic and resistance exercises

16 weeks

7 testing visits, 48 exercise training visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 months

What Are the Treatments Tested in This Trial?

Interventions

• CARE
• Home-Based Stretching

Trial Overview The study tests if a 16-week exercise program can reduce inflammation in fat tissue of breast cancer survivors. It involves TARE (Targeted Radiotherapy), Home-Based Stretching, and CARE (Comprehensive Assessment and Response Evaluation).

How Is the Trial Designed?

Group I: Traditional Aerobic Resistance Exercise (TARE) Experimental Treatment 1 Intervention

This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months \- 16 weeks of traditional aerobic and resistance exercise

Group II: Circuit-style aerobic and resistance Exercise(CARE) Experimental Treatment 1 Intervention

This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months. -16 weeks of circuit-style aerobic and resistance exercise

Group III: Home-Based Stretching Active Control 1 Intervention

Attention Control for 16 weeks home-based stretching -structured home-based stretching program, participants will be asked to maintain their current activity level for the 4-month study duration, and will be offered the CARE program upon study completion

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A creative therapeutic exercise program, including supervised group dance sessions, has been integrated into the preoperative and postoperative care for breast cancer patients since 1982, emphasizing the importance of physical therapy in their recovery.

This approach not only addresses the physical rehabilitation needs but also supports emotional well-being, helping patients adjust to changes in body image and fostering a positive attitude through shared experiences in a supportive group setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy and dance in the surgical management of breast cancer. A clinical report. Molinaro, J., Kleinfeld, M., Lebed, S.[2019]

A 5-year study involving 2500 adult cancer survivors in Alberta, Canada, is evaluating the effectiveness of a community-based exercise program designed to improve physical functioning and quality of life after cancer treatment.

Participants will engage in mild-to-moderate intensity exercise for 12 weeks, with the primary goal of having at least 150 minutes of exercise per week at the 1-year follow-up, aiming to provide insights into the long-term benefits of exercise on cancer recurrence and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. McNeely, ML., Sellar, C., Williamson, T., et al.[2023]

A review of 229 articles revealed that 'home-based exercise' can refer to a variety of settings, including at-home, outdoors, or in community facilities, highlighting the need for clearer definitions in research.

Support for home-based exercise interventions varies widely, with elements such as supervision, printed materials, equipment, and technology being used, suggesting that tailored approaches may enhance the effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability and limitations in home-based exercise program descriptions in oncology: a scoping review. Lopez, C., McGarragle, K., Pritlove, C., et al.[2020]

The Strong for Life exercise program was successfully implemented with 105 frail, homebound older adults, showing high satisfaction rates of 100% among volunteers and 98.6% among participants after 4 months.

Participants engaged in exercise an average of 2.2 times per week, with over half exercising 2 to 4 times weekly, leading to significant improvements in social functioning without any serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of implementing the Strong for Life program in community settings. Etkin, CD., Prohaska, TR., Harris, BA., et al.[2019]

A home-based exercise program for breast cancer survivors significantly improved upper body strength and shoulder range of motion after 16 weeks, involving 89 women aged around 55 years.

However, the intervention did not lead to significant changes in overall physical fitness, sedentary behavior, or disability measures, suggesting that additional strategies may be needed to enhance broader health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Exercise Intervention in the Fitness Profile of Hispanic Survivors of Breast Cancer. Ortiz, A., Hughes, DC., Mama, SK., et al.[2022]

The HEALTh program, a customized cardiac rehabilitation model for female breast cancer survivors, significantly improved cardiorespiratory fitness by 14% and enhanced quality of life and reduced depressive symptoms after 22 sessions.

With a program adherence rate of 66.6%, the study involved 152 breast cancer survivors, demonstrating that structured exercise and education can effectively support physical and mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. Dolan, LB., Barry, D., Petrella, T., et al.[2019]

A systematic review of 58 publications identified 34 exercise programs for cancer survivors conducted in home or community settings, highlighting the diversity of interventions available.

The review revealed significant gaps in reporting on the implementation processes and contextual factors affecting these programs, indicating a need for more detailed studies to enhance future community-based exercise interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. Neil-Sztramko, SE., Smith-Turchyn, J., Fong, A., et al.[2022]

Technology-assisted interventions, such as telephone and mobile applications, have been effective in improving physical activity and overall health in breast cancer patients, with a majority of participants expressing satisfaction with these methods.

During the Covid-19 pandemic, virtual communication became crucial for supporting breast cancer patients, enhancing their treatment adherence and mental well-being despite challenges posed by the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation and Monitoring Physical Activity in Patient with Breast Cancer: Systematic Review. Keikha, L., Maserat, E., Mohammadzadeh, Z.[2022]

Mobilization stretches and exercises after breast cancer surgery effectively improve shoulder range of motion and reduce chest tightness and pain, enhancing the quality of life for patients.

Nurses play a crucial role in encouraging and teaching postoperative exercise to breast cancer patients to help minimize the side effects of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for the Patient after Breast Cancer Surgery. Wilson, DJ.[2018]

Home-based exercise programs for older adults can significantly reduce the fear of falling, providing moderately certain evidence of their effectiveness based on a systematic review of 11 studies involving 1004 participants.

These programs also show potential for improving psychosocial outcomes, such as mental health and quality of life, as well as mobility, although the evidence for these benefits is less certain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Indoor Physical Activity Programs for Community-Dwelling Older Adults: A Systematic Review. Santos, IKD., Cobucci, RN., Medeiros, JA., et al.[2023]

A study involving 50 patients undergoing preoperative treatment for pancreatic cancer found that social support and neighborhood walkability positively influenced their physical activity levels during treatment.

Patients reported that encouragement from healthcare providers and their motivation to complete treatment were key factors in adhering to home-based exercise prescriptions, highlighting the importance of interpersonal and environmental support in exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. Parker, NH., Lee, RE., O'Connor, DP., et al.[2023]

A randomized controlled trial involving 76 breast cancer survivors tested a 12-week telephone-based physical activity intervention delivered by trained volunteers, but the intervention did not show significant effects on physical health, mental health, or quality of life outcomes.

The study found that factors such as age, chemotherapy use, and baseline health status significantly influenced how effective the physical activity intervention was, suggesting that these variables should be considered when designing future programs for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer mentorship to promote physical activity among cancer survivors: effects on quality of life. Pinto, B., Stein, K., Dunsiger, S.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11184867/

Effectiveness of exercise modalities on breast cancer ... Overall exercise significantly improves the HRQOL, CRF and physical function in patients with BC. HRQOL was improved with all exercise types.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32020706/

Circuit resistance training and cardiovascular health in ... 12 weeks CRT improves muscle and cardiorespiratory fitness and is also an effective strategy for decreasing a proven cardiovascular risk factor in breast ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00877188

Effect of Combined Aerobic and Resisted Exercise in ... The purpose of this study is to evaluate the effects of a combined aerobic and resistance exercise program in breast cancer survivors.

4. sportsmedicine-open.springeropen.com sportsmedicine-open.springeropen.com/articles/10.1186/s40798-025-00872-3

Comparative Efficacy of Different Exercise Therapies for ... found a significant improvement in CRF in breast cancers after 12 weeks of moderate to high intensity aerobic training compared with usual care ...

5. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-018-1051-6

Aerobic and resistance exercise improves physical fitness ... A 16-week combined aerobic and resistance exercise program designed to address metabolic syndrome in ethnically-diverse overweight or obese breast cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5858524/

Effects of Aerobic and Resistance Exercise on Metabolic ... Our findings suggest a targeted exercise prescription for improving metabolic syndrome in survivors of breast cancer and support the incorporation of supervised ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5440970/

Combined aerobic and resistance training improves bone ... These results suggest that CART is safe and feasible for female cancer survivors and could help improve bone health. With the increased number ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824547

Aerobic Physical Activity and Depression Among Patients ... Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: a multicenter randomized controlled trial.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00665080

Study Details | NCT00665080 | Aerobic Exercise, ... PURPOSE: This randomized clinical trial is studying aerobic exercise to see how well it works compared with resistance exercise or flexibility and relaxation ...