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Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
Recruiting
Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming (GAMMER) Study in Early Stage Breast Cancer Receiving Chemotherapy
Who can join
Ages 18 and older · Women
Full eligibility criteria
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 * Diabetes * History of eating disorder * Serious/uncontrolled medical condition (e.g. end stage renal disease on dialysis, cirrhosis, uncontrolled hypertension, seizure disorder, history of bariatric surgery) * Pregnant or nursing * Use of medications that must be taken with food: allopurinol, aspirin, amiodarone, baclofen, bromocriptine, carvedilol, carbamezpine, cimetidine, diclofenac, doxycycline, fenofibrate, fludrocortisone, glyburide, hydrocortisone, iron supplements, ketorolac, lithium, methylprednisolone, naproxen, niacin, potassium salts, prednisone, procainamide, sevelamer, sulfasalazine, trazodone, valproic acid
About the study
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.
What is being tested
- Fasting (behavioral)
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Participants: 30 · Started: Aug 8, 2024
Contact the study team
- Jennifer Sheng, MD · Phone: 202-537-4000
Official record on ClinicalTrials.gov — NCT06536881
Locations in the U.S.
| District of Columbia | Sibley Memorial Hospital, Washington D.C. |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.