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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates the feasibility of exercise during chemotherapy in older women with stage I-III breast cancer. Previous studies have reported that exercise may reduce the chemotherapy-toxicity risk. This trial may help researchers learn if engaging in a physical activity program is feasible in patients receiving chemotherapy for breast cancer.

Research Team

Meghan Karuturi

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+