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NCT06536881
Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
Conditions: Breast Cancer, Early-stage Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Location: Sibley Memorial Hospital Washington D.C. District of Columbia
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT06536881). StuddyBuddy aggregates publicly available trial information.
