Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise and Medical Nutrition.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)
Overview
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.
Detailed 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.
Interventions
- Behavioral Exercise and Medical Nutrition
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.
Primary outcome measures
- Pathologic Complete Response (pCR) [Time frame: Post breast cancer surgery, an average of 6 months]
Secondary outcome measures (1)
- Residual Cancer Burden (RCB) [Time frame: Post breast cancer surgery, an average of 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Having already started a 2nd chemotherapy cycle.
- Pregnancy or intention to become pregnant.
- Presence of dementia or major psychiatric disease.
- Recent (past year) stroke, myocardial infarction, or congestive heart failure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Yale University — New Haven
Identifiers
NCT: NCT07066189 · 2000039695