Understanding gut bacteria changes and their effects on fatigue and nausea in breast cancer patients undergoing chemotherapy
Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles
This study is trying to see how changes in gut bacteria might affect fatigue and nausea in women with early stage breast cancer who are going through chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Scottsdale, Arizona and 4 other locations) |
| Trial ID | NCT05417867 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to explore the relationship between gut microbiome changes and the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women with early stage breast cancer. Participants will provide stool and blood samples before and after chemotherapy, along with completing questionnaires regarding their symptoms and health status. The study will assess the feasibility of recruitment and retention, as well as estimate the effect size of microbiome changes associated with fatigue and CIN. By analyzing these associations, the study seeks to uncover potential links that could inform future interventions.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 and older with early stage breast cancer scheduled to receive moderate to highly emetogenic chemotherapy.
Not a fit: Patients with metastatic disease, those undergoing concurrent radiation therapy, or those receiving antibiotic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for fatigue and nausea in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While the specific approach of linking gut microbiome changes to fatigue and CIN in breast cancer patients is novel, similar studies have shown promising results in other cancer populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida * At least 20 years of age * Last chemotherapy more than 3 years ago * Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies Exclusion Criteria: * Metastatic disease * Concurrent radiation therapy * Concurrent antibiotic treatment
Where this trial is running
Scottsdale, Arizona and 4 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Suspended)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Active_not_recruiting)
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (Recruiting)
- Mayo Clinic Health System in Mankato — Mankato, Minnesota, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Suspended)
Study contacts
- Principal investigator: Brenda J. Ernst, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.