Lifestyle, exercise, and nutrition program to improve response in triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study enrolls women with stage II–III triple-negative breast cancer who are scheduled for neoadjuvant chemo-immunotherapy and currently do less than 150 minutes of exercise per week. After baseline assessment and consent, participants are randomly assigned to weekly 30-minute remote nutrition and exercise counseling plus a home-based exercise regimen or to usual care for the duration of chemotherapy. Study visits include two in-person assessments with blood draws, a 6-minute walk test, and DXA scans to measure body composition. The primary outcome is pathologic complete response (no residual cancer in the breast) with secondary outcomes including residual cancer burden, treatment-related symptoms, body composition, and blood biomarkers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female aged 18 years or older.
2. Have a diagnosis of stage II or III Triple Negative Breast Cancer (TNBC).
3. Be scheduled to receive neoadjuvant chemo-immunotherapy.
4. Be physically able to walk.
5. Be able to complete forms, understand instructions and read in English.
6. Agree to be randomly assigned to either group.
7. Have clearance from oncologist to participate.
8. Not exercising (less than 150 min/week).
9. Not consuming more than 7 fruits and vegetable/day.

Exclusion Criteria:

1. Having already started a 2nd chemotherapy cycle.
2. Pregnancy or intention to become pregnant.
3. Presence of dementia or major psychiatric disease.
4. Recent (past year) stroke, myocardial infarction, or congestive heart failure.

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Melinda Irwin — Yale University
• Study coordinator: Melinda Irwin
• Email: melinda.irwin@yale.edu
• Phone: 203-785-6392

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.