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Fasting-Mimicking Diet as an Adjunct to Neoadjuvant Chemotherapy for Hormone-Receptor-Positive Breast Cancer
Sponsor: Guangdong Provincial People's Hospital
Summary
This is a phase II, Single-Arm Clinical Study evaluating the efficacy and safety of a fasting-mimicking diet (FMD) combined with neoadjuvant chemotherapy in patients with ER-positive, HER2-negative breast cancer. Participants will be assigned to Intervention group: 4-day FMD cycles (827± 100kcal/day on Day 1, 637± 100kcal/day on Days 2-4) synchronized with T-EC chemotherapy. The primary endpoint is pathological complete response (pCR) rate. Secondary endpoints include metabolic changes, immune markers, quality of life, and safety (CTCAE v5.0). A total patients will be enrolled to detect a 15% pCR improvement (25% vs. 10%, α=0.05, power=80%).
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-07-12
Completion Date
2026-12-30
Last Updated
2025-07-22
Healthy Volunteers
No
Interventions
Fasting-mimicking diet (FMD) Group
The FMD will consist of a triweekly 4-day regimen of a plant-based, calorie-restricted (827± 100 kcal on day 1;637 ± 100 kcal on days 2-4), low-carbohydrate, low-protein diet. The FMD will be repeated up to a maximum of eight consecutive cycles. Participants receive the FMD for 2 days prior to and on the day and one day after each cycle of chemotherapy.
Locations (1)
Guangdong Provincial People's Hospital
Guangzhou, China