Evaluating the Association Among Changes in Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer
Recruiting · NCT05417867 · Observational (researchers observe without assigning treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
5 locations listed across 3 US states.
- Mayo Clinic in Arizona - Scottsdale, Arizona, United States
- Mayo Clinic in Florida - Jacksonville, Florida, United States
- Mayo Clinic Health System in Albert Lea - Albert Lea, Minnesota, United States
- Mayo Clinic Health System in Mankato - Mankato, Minnesota, United States
- Mayo Clinic in Rochester - Rochester, Minnesota, United States