Actively Recruiting
Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-08-17
30
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
T
The Commonwealth Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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) performance status 0-1 confirmed by provider
- Body mass index (BMI) of 19.5 kg/m2 or higher as documented in medical record
- Willingness to change diet and provide fecal samples three times during the study
You will not qualify if you...
- Body mass index (BMI) less than 19.5 kg/m2
- Diagnosis of diabetes
- History of eating disorder
- Serious or uncontrolled medical conditions such as end stage renal disease on dialysis, cirrhosis, uncontrolled hypertension, seizure disorder, or history of bariatric surgery
- Pregnant or nursing
- Use of medications that must be taken with food, including 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, or valproic acid
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
Research Team
J
Jennifer Sheng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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