Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Female aged 18 years or older.

• Have a diagnosis of stage II or III Triple Negative Breast Cancer (TNBC).

• Be scheduled to receive neoadjuvant chemo-immunotherapy.

• Be physically able to walk.

• Be able to complete forms, understand instructions and read in English.

• Agree to be randomly assigned to either group.

• Have clearance from oncologist to participate.

• Not exercising (less than 150 min/week).

• Not consuming more than 7 fruits and vegetable/week.

Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Contact Information
Primary
Melinda Irwin
melinda.irwin@yale.edu
203-785-6392
Time Frame
Start Date: 2025-10-17
Estimated Completion Date: 2029-10
Participants
Target number of participants: 160
Treatments
Experimental: Exercise and Medical Nutrition
Women randomized to the intervention will receive 10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. In weeks in which one of the 10 counseling sessions is not scheduled the interventionist will observe the participant in an exercise session via zoom, or check in with the participant by phone regarding their exercise. The intervention will continue until the day prior to the last chemotherapy infusion.
No_intervention: Usual care
Contact limited to study assessments.
Related Therapeutic Areas
Breast Cancer
Triple-Negative Breast Cancer
Sponsors
Collaborators: Breast Cancer Research Foundation
Leads: Yale University

This content was sourced from clinicaltrials.gov

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