Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study ID
- NCT06536881
- Status
- Recruiting
Conditions
- Breast Cancer
- Early-stage Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fasting — BEHAVIORALThe 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).
Study Details
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.
Key Dates
- Start date
- Aug 8, 2024
- Status verified
- Aug 2025
- Primary completion
- Aug 31, 2028
- Completion
- May 31, 2029
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- OTHER
Arms
- Experimental: Fasting prior to chemotherapyPrior 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).
Primary Outcome Measure
Proportion of participants with self-reported adherence to the fasting regimen [ Time Frame: 6 -8 months ]
Central Contacts
- Jennifer Sheng, MD202-537-4000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 |
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