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An Exercise and Nutrition Program for the Improvement of Pathologic Complete Response in Women with Stage II and III Triple-Negative Breast Cancer Receiving Neoadjuvant Therapy, LEAN Trial
Trial Status: active
This phase II trial studies whether an exercise and nutrition program helps improve rates of pathologic complete response (pCR) (meaning no cancer is seen in the breast after chemotherapy) in women with stage II and III triple-negative breast cancer (TNBC) receiving chemotherapy and immunotherapy before surgery (neoadjuvant). Despite recent improvements in outcomes with the addition of immunotherapy to neoadjuvant chemotherapy for stage II and III TNBCs, these cancers remain deadly. TNBC survival is strongly associated with pCR, and it is thought that exercise and a healthy diet may help improve pCR, but there is limited research on this in breast cancer patients. The exercise and nutrition program in this study offers personalized counseling sessions throughout the patient's neoadjuvant therapy. The counseling sessions are provided by a Registered Dietitian who has specialized training in cancer nutrition and exercise science, and they aim to help patients achieve exercise and nutrition goals and improve the patient's weekly exercise time and diet. This may be an effective way to help improve pCR in women with stage II and III TNBC receiving neoadjuvant chemotherapy and immunotherapy.
Inclusion Criteria
Female aged 18 years or older
Have a diagnosis of stage II or III TNBC
Be scheduled to receive neoadjuvant chemotherapy (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 (< 150 minutes [min]/week)
Not consuming > 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
Additional locations may be listed on ClinicalTrials.gov for NCT07066189.
Locations matching your search criteria
United States
Connecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Fairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Greenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Guilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
New Haven
Yale University
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
North Haven
Yale-New Haven Hospital North Haven Medical Center
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Orange
Smilow Cancer Hospital-Orange Care Center
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Torrington
Smilow Cancer Hospital-Torrington Care Center
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Waterbury
Smilow Cancer Hospital-Waterbury Care Center
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Waterford
Smilow Cancer Hospital Care Center - Waterford
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
Rhode Island
Westerly
Smilow Cancer Hospital Care Center - Westerly
Status: Active
Contact: Melinda L. Irwin
Phone: 203-645-5995
PRIMARY OBJECTIVE:
I. We propose, among 160 women who are newly diagnosed with TNBC initiating standard of care neoadjuvant chemotherapy and immunotherapy, a novel phase II randomized therapeutic trial of exercise and medical nutrition therapy versus (vs.) usual care, on pathologic complete response (pCR) as the primary outcome.
SECONDARY OBJECTIVE:
I. Residual cancer burden (RCB), a continuous pCR score.
TERTIARY/EXPLORATORY OBJECTIVES:
I. Examine the effect of the intervention vs. usual care on mechanisms potentially mediating intervention effects on pCR and RCB, including serum metabolic, inflammation and immune biomarkers, body composition, adherence to prescribed neoadjuvant treatment regimens, and chemotoxicity assessed via patient reported outcomes.
II. Examine changes in exercise and diet quality from baseline to end of neoadjuvant therapy and 1-month post-surgery by randomization group, as well as intervention fidelity and acceptability among those randomized to intervention.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend personalized exercise and nutrition counseling sessions over 30 minutes each once a week (QW) for 4 weeks, once every 2 weeks (Q2W) for weeks 5-10, and once every 4 weeks (Q4W) in weeks 11-24, continuing until the day prior to the last neoadjuvant chemotherapy infusion for a total of 10 sessions in the absence of unacceptable toxicity. Patients also receive exercise and nutrition goals to meet, virtual or phone check-ins, a recipe book, dumbbells, and a FitBit on study.
ARM II: Patients receive usual care with access to consultations with Registered Dietitians and Physical Therapists at the discretion of their treating provider throughout their neoadjuvant chemotherapy. Patients also receive the Lifestyle, Exercise, and Nutrition (LEAN)-pCR intervention book and a FitBit and may optionally attend one session with the interventionist upon the completion of post-chemotherapy assessments.
Additionally, all patients undergo dual energy x-ray absorptiometry (DXA) and blood sample collection throughout the study.
After completion of study intervention, patients are followed up at 1-56 days following the last chemotherapy infusion/cycle and 1 month post-surgery.
