Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming (GAMMER) Study in Early Stage Breast Cancer Receiving Chemotherapy
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Jennifer Sheng, MD
jsheng7@jhmi.edu
202-537-4000
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2029-05
Participants
Target number of participants: 30
Treatments
Experimental: Fasting prior to chemotherapy
Prior to chemotherapy administration, a trial of a 24-hour water-only fast will be conducted; at least 1 successful 24-hour fast is required to proceed with the fasting intervention during chemotherapy. A total of 3 trials is allowed (for a maximum of 48 hours fasting).
Related Therapeutic Areas
Sponsors
Collaborators: The Commonwealth Fund, Maryland Cigarette Restitution Fund
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins