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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

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Participants: 30 · Started: Aug 8, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06536881

Locations in the U.S.

District of ColumbiaSibley 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.