RecruitingNot ApplicableNCT06536881

Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming (GAMMER) Study in Early Stage Breast Cancer Receiving Chemotherapy

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

30 participants

Start Date

Aug 8, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria6

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

Interventions

BEHAVIORALFasting

The dietician will review the patient's chemotherapy schedule, and confirm the fasting window (as windows may be 24, 26 or 48 hours; and chemotherapy start times can vary from patient to patient).