Status:
RECRUITING
Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
The Commonwealth Fund
Maryland Cigarette Restitution Fund
Conditions:
Breast Cancer
Early-stage Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 aft...
Detailed Description
Breast cancer is the most common cancer diagnosed among women worldwide. Many women diagnosed with early stage breast cancer (ESBC) will receive systemic therapy consisting of cytotoxic chemotherapy. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06536881
Start Date
August 8 2024
End Date
May 1 2029
Last Update
August 17 2025
Active Locations (1)
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1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016