Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
Recruiting · NCT06536881 · Interventional (participants receive a specific treatment) · Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
View the official record on ClinicalTrials.gov →Interventions studied
Fasting
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Sibley Memorial Hospital - Washington D.C., District of Columbia, United States