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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07066189
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise and Medical Nutrition — BEHAVIORAL
    10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. On weeks counseling is not scheduled an exercise session will be observed.

Study Details

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.

Key Dates

Start date
Oct 17, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Pathologic Complete Response (pCR) [ Time Frame: Post breast cancer surgery, an average of 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511
Melinda Irwin, PhD
[email protected]
203-785-6392

Find similar trials in New Haven, CT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Yale University· New Haven, CT

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