Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming (GAMMER) Study in Early Stage Breast Cancer Receiving Chemotherapy
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
This research is being done to test the feasibility of 24-48 hours of water-only fasting to improve delivery of 4 cycles of chemotherapy in those receiving breast cancer treatment either before or after surgery.
Description
Breast cancer is the most common cancer diagnosed among women worldwide. Many women diagnosed with early stage breast cancer (ESBC) will receive systemic therapy consisting of cytotoxic chemotherapy. As therapy-related toxicities are the most common reason for non-completion or dose reduction of chemotherapy, new strategies are needed to mitigate adverse effects. Preclinical studies show that fasting can prevent toxic effects of oxidative stress and chemotherapy without causing chronic weight loss via modulation of key oncogenic pathways. A few studies in women with breast cancer have demonstr…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosed with histologically-confirmed stage I-III invasive carcinoma of the breast * Planning for standard neoadjuvant or adjuvant chemotherapy ddAC or TC for 4 cycles (concurrent anti-HER2 therapy is permitted) * Provider physical exam within 4 weeks of consent * Eastern Cooperative Oncology Group (ECOG) 0-1 (as per recent provider note or direct confirmation with provider) * BMI ≥ 19.5 kg/m2 (as per most recent visit documented in medical record) * Willingness to change diet, and provide fecal sample 3 times during study Exclusion Criteria: * BMI \<19.5 kg/m2 * Dia…
Interventions
- BehavioralFasting
The dietician will review the patient's chemotherapy schedule, and confirm the fasting window (as windows may be 24, 26 or 48 hours; and chemotherapy start times can vary from patient to patient).
Location
- Sibley Memorial HospitalWashington D.C., District of Columbia