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Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
RECRUITINGN/ASponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Actively Recruiting
PhaseN/A
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Started2024-08-08
Est. completion2028-08
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06536881
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 after surgery.
Eligibility
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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
Conditions3
Breast CancerCancerEarly-stage Breast Cancer
Locations1 site
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
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Actively Recruiting
PhaseN/A
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Started2024-08-08
Est. completion2028-08
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06536881