Clinical trial · Interventional
Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC
Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)
NCT07066189CI-TRIAL-00096855recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise and Medical Nutrition | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise and Medical Nutrition
- 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.
- interventionNames
- Behavioral: Exercise and Medical Nutrition
- type
- NO_INTERVENTION
- label
- Usual care
- description
- Contact limited to study assessments.
Primary outcomes (1)
- measure
- Pathologic Complete Response (pCR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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/day. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.