NCT05417867 Evaluating the Association Among Changes in Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer
| NCT ID | NCT05417867 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Chemotherapy-Related Nausea and/or Vomiting |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-04-14 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2021-04-14 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot study seeks to understand how changes in the bacteria composition (microbiome) of the gut may be associated with the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for early stage breast cancer. Patients undergoing chemotherapy may experience fatigue or nausea as a result of their treatment. Known risk factors for fatigue and CIN do not explain the differences in fatigue and CIN occurrence between patients, but changes in the functions of the gut microbiome may be related to the occurrence of fatigue and CIN. This study collects stool samples from breast cancer patients before and after chemotherapy to evaluate how changes in the microbiome may be associated with fatigue and CIN.
Eligibility 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
Contact & Investigator
Brenda J. Ernst, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05417867 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Chemotherapy-Related Nausea and/or Vomiting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05417867 currently recruiting?
Yes, NCT05417867 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT05417867 trial being conducted?
This trial is being conducted at Scottsdale, United States, Jacksonville, United States, Albert Lea, United States, Mankato, United States and 1 additional location.
Who is sponsoring the NCT05417867 clinical trial?
NCT05417867 is sponsored by Mayo Clinic. The principal investigator is Brenda J. Ernst, MD at Mayo Clinic. The trial plans to enroll 70 participants.