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

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

Plain Language Summary

Simplified for easier understanding

This study examines how gut bacteria (the microbiome) change during breast cancer chemotherapy and whether these changes are linked to side effects, metabolism, and treatment response. Participants will provide stool samples and follow dietary guidance during treatment. **You may be eligible if...** - You have confirmed Stage I–III invasive breast cancer - You are scheduled to receive standard neoadjuvant or adjuvant chemotherapy (ddAC or TC regimen) - You have a BMI of at least 19.5 - You are willing to modify your diet and provide 3 stool samples during the study **You may NOT be eligible if...** - You have diabetes - You have a history of an eating disorder - You have serious uncontrolled conditions (e.g., kidney failure, liver cirrhosis) - You are pregnant or nursing - You take certain medications that require food (listed in the study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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).


Locations(1)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06536881


Related Trials