Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC
Recruiting · NCT07066189 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
Exercise and Medical Nutrition
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Yale University - New Haven, Connecticut, United States