Status:
RECRUITING
Evaluating the Association Between Changes in the Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Chemotherapy-Related Nausea and/or Vomiting
Early Stage Breast Carcinoma
Eligibility:
All Genders
20+ years
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 und...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the feasibility of patient recruitment and retention, as well as specimen collection. II. Estimate the effect size for changes in gut microbiome composition profiles ...
Eligibility Criteria
Inclusion
- 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
- Metastatic disease
- Concurrent radiation therapy
- Concurrent antibiotic treatment
Key Trial Info
Start Date :
April 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05417867
Start Date
April 14 2021
End Date
March 1 2027
Last Update
October 27 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
3
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
4
Mayo Clinic Health System in Mankato
Mankato, Minnesota, United States, 56001