Gut Microbiome Changes for Chemotherapy Symptoms in Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the relationship between changes in gut bacteria and fatigue and nausea in women receiving chemotherapy for early-stage breast cancer. Researchers will collect stool samples from patients before and after chemotherapy to determine if shifts in gut bacteria are linked to these side effects. Women with early-stage breast cancer who are about to undergo chemotherapy likely to cause nausea may be suitable candidates. Participants should not be receiving radiation or antibiotics concurrently. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the quality of life for future chemotherapy patients.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but you cannot participate if you are currently on antibiotics.
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to explore the connection between the gut microbiome and symptoms like fatigue and nausea caused by chemotherapy in early-stage breast cancer patients. Unlike traditional approaches that focus directly on managing these symptoms through medication, this trial looks at how changes in the gut's bacteria might influence these side effects. By collecting stool and blood samples and using questionnaires, the study could uncover new insights into how gut health affects overall wellbeing during chemotherapy. This could potentially lead to more personalized and effective management strategies for patients in the future.
Who Is on the Research Team?
Brenda J. Ernst, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Collection of baseline stool and blood samples and completion of questionnaires
Chemotherapy
Participants undergo chemotherapy treatment and provide stool and blood samples 3-5 days after initiation
Follow-up
Participants are monitored for changes in gut microbiome composition and symptoms associated with fatigue and CIN
What Are the Treatments Tested in This Trial?
Interventions
- Biospecimen Collection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator