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Observational for Breast Cancer
N/A
Recruiting
Led By Komal P. Singh, Ph.D., R.N.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month after chemotherapy treatment completion
Awards & highlights
Study Summary
This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 month after chemotherapy treatment completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month after chemotherapy treatment completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in GI inflammation
Change in GI microbiome profile
Symptom burden - LFS
+2 moreSecondary outcome measures
Associations between microbial composition functional profiles and symptom severity
Change in metabolite abundance
Trial Design
1Treatment groups
Experimental Treatment
Group I: ObservationalExperimental Treatment1 Intervention
Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,744 Total Patients Enrolled
83 Trials studying Breast Cancer
13,912 Patients Enrolled for Breast Cancer
Komal P. Singh, Ph.D., R.N.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
44 Total Patients Enrolled
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