Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About this trial
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
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Fasting
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
The Commonwealth Fund
Collaborator
Maryland Cigarette Restitution Fund
Collaborator
Source ClinicalTrials.gov