Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC

Yale University

Status: Enrolling

Conditions: Triple Negative Breast Cancer

Treatments: Behavioral: Exercise and Medical Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT07066189

2000039695

Details and patient eligibility

About

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.

Full description

Women with stage II-III triple-negative breast cancer (TNBC) undergoing neoadjuvant chemo-immunotherapy will be enrolled in the study. Following screening, consent, and baseline assessment, participants will be randomized to either the intervention group (nutrition and exercise counseling) or the usual care group. Participants randomized to the intervention group will complete weekly remote sessions with the interventionist throughout the duration of chemotherapy. Each counseling session will last about 30 minutes and will be conducted remotely. The exercise regimen is home-based.

Study activities include completing surveys and attending two in-person study visits, each of which will include a blood draw, a 6-minute walk test to assess aerobic capacity and endurance, and a Dual Energy X-Ray Absorptiometry (DXA) scan to measure body composition.

The primary outcome is the pathologic complete response.

Researchers will also compare the exercise and nutrition program to usual care to determine if the program improves residual cancer burden, symptoms related to cancer treatment, body composition, and blood biomarkers.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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/week.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Exercise and Medical Nutrition

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise and Medical Nutrition

Usual care

No Intervention group

Description:

Contact limited to study assessments.