Exercise During Chemotherapy for Breast Cancer

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Significant medical conditions, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether older women with stage I-III breast cancer can safely and effectively exercise during chemotherapy. Exercise may reduce chemotherapy side effects, and researchers aim to determine if a program combining walking and strength training is feasible and beneficial. Participants will receive coaching, use a fitness tracker, and follow a structured exercise plan, known as the Exercise Intervention. This trial suits women aged 65 or older with stage I-III breast cancer who can walk and are about to begin chemotherapy. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance quality of life during chemotherapy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise intervention is safe for older women with breast cancer?

Research shows that exercising during chemotherapy for breast cancer is generally safe and manageable. Studies have found that exercise does not lead patients to stop chemotherapy early, allowing them to continue treatment while staying active. Other research indicates that exercise can lower the risk of cancer recurrence and may reduce death rates among breast cancer patients.

Overall, evidence supports the safe integration of exercise into chemotherapy treatment for breast cancer without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise as a supportive treatment during chemotherapy for breast cancer because it offers a holistic approach that goes beyond traditional medical treatments. Unlike chemotherapy or hormone therapies that focus directly on attacking cancer cells, this exercise intervention emphasizes improving patients' overall well-being through personalized coaching and physical activity. The program encourages patients to engage in regular walking and strength training, which could help reduce fatigue, improve mood, and enhance physical resilience during and after chemotherapy. This focus on integrating physical activity into cancer care represents a shift towards addressing the quality of life for patients alongside the primary cancer treatment.

What evidence suggests that exercise is effective during chemotherapy for breast cancer?

Research shows that exercise can aid breast cancer treatment. In this trial, participants will follow a structured exercise program during chemotherapy. Studies find that patients who exercise during chemotherapy are less likely to stop treatment early. Exercise also encourages continued activity after the program ends. Evidence suggests that staying active may lower the risk of breast cancer recurrence and reduce death rates. While exercise might not enhance every aspect of quality of life, it still offers significant health benefits during treatment. ^{1 4 5 6 7}

Who Is on the Research Team?

Meghan Karuturi

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women aged 65 or older with Stage I-III breast cancer, about to start chemotherapy. They must be able to walk, do moderate exercise, and commit to the study's requirements. Women with serious medical conditions that prevent them from exercising cannot participate.

Inclusion Criteria

Scheduled to begin adjuvant or neoadjuvant chemotherapy regimen either as standard-of-care or on study

English or Spanish speaking

Able to provide written, informed consent

Exclusion Criteria

The presence of significant medical conditions that in the physician's judgement preclude participation in the exercise intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy and Exercise Intervention

Participants receive chemotherapy and engage in a home-based exercise intervention, including walking and strength training, with weekly coaching sessions.

Duration of chemotherapy (typically 12-24 weeks)

Weekly coaching sessions (virtual or in-person)

Follow-up

Participants are monitored for safety, effectiveness, and adherence to the exercise program up to 1 month after chemotherapy.

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

Trial Overview The trial tests if it's practical for older women receiving chemotherapy for breast cancer to follow an exercise program. It includes questionnaires, discussions, using a medical device, quality-of-life assessments, and educational interventions about physical activity.

How Is the Trial Designed?

Group I: Supportive care (coaching, exercise, questionnaire) Experimental Treatment 6 Interventions

Patients participate in one-on-one coaching sessions with a health coach QW to discuss the content offered in the program, and challenges they are currently facing in achieving their exercise goals. Patients receive a copy of the WWE workbook, wear a fitness tracker and are encouraged to achieve 150 minutes of walking per week during chemotherapy and up to 1 month after chemotherapy. Patients also participate in the Growing Stronger Strength Training Program and receive instruction manuals. They perform the initial 2 exercises 2 days per week for 4 weeks, and subsequent 2 exercises 2 days per week for the remainder of the chemotherapy course. Patients maintain exercise logs and complete questionnaires over 30-45 minutes at baseline, end of chemotherapy and at 1 month after chemotherapy.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5981588/

Physical Activity, Exercise and Breast Cancer It appears that exercise can positively influence certain cancer- and treatment-related side effects, quality of life, recurrence, and survival.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2095254625000432

Effects of aerobic or resistance exercise during ... The rate of premature discontinuation of chemotherapy was significantly lower among patients receiving an exercise intervention compared to controls, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9873715/

Long-term effects of exercise interventions on physical ... The physical activity behaviour in breast cancer patients remained improved for several months beyond the end of exercise interventions, but effects were small.

4. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-01634-6

Outcomes of physical exercises on initiation, progression, and ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2006.08.2024

Effects of Aerobic and Resistance Exercise in Breast ... Neither aerobic nor resistance exercise significantly improved cancer-specific QOL in breast cancer patients receiving chemotherapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11075339/

Outcomes of physical exercises on initiation, progression, ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

7. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-025-04865-8

Exercise-based interventions for preventing and treating ... The meta-analysis showed that exercise-based interventions had a significant effect on resting HR among patients with cancer (six trials; MD: - ...