Recruiting
Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
About this study
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.
- Condition
- Breast Cancer, Early-stage Breast Cancer
- Tested
- Fasting
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Who can join
- Age
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 18 years
- Eligible sex: Female
- Study condition: Breast Cancer, Early-stage Breast Cancer
- 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 6
- 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
1 site, 1 recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Contact
-
Jennifer Sheng, MD
202-537-4000 jsheng7@jhmi.edu
Potential match only. Final eligibility is determined by the study team.