Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Early-stage Breast Cancer

In brief

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 facts

Study ID

NCT06536881

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

30

Starts

2024-08-08

Expected to finish

2029-05-01

Last updated by the study team

2025-08-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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