Actively Recruiting
Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles in Early Stage Breast Cancer
Led by Mayo Clinic · Updated on 2026-03-31
70
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how changes in the gut bacteria (microbiome) might be linked to fatigue and chemotherapy-induced nausea (CIN) in women with early stage breast cancer. Since patients receiving chemotherapy often experience these symptoms, this observational study aims to explore why some patients have more fatigue and nausea than others, focusing on the role of the gut microbiome. The study is supported by Mayo Clinic and collects data before and after chemotherapy treatment. Participants provide stool and blood samples before starting chemotherapy and again 3 to 5 days after chemotherapy begins. They also complete questionnaires about their symptoms, food intake, exercise, and other health factors. The study observes changes in gut bacteria composition and metabolites to understand their connection to fatigue and CIN during chemotherapy. During the study, patients are asked to complete questionnaires and provide biological samples at two time points: before chemotherapy and shortly after treatment starts. Researchers monitor the bacterial makeup of stool samples and compare demographic and clinical characteristics between patients who do and do not report fatigue or nausea. The study tracks recruitment, retention, and the completion of study assessments over up to 24 months, aiming to better understand symptom differences related to chemotherapy.
CONDITIONS
Brief Title
Evaluating the Association Among Changes in Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with early stage breast cancer
- Planning to receive moderate to highly emetogenic chemotherapy
- At least 20 years of age
- Last chemotherapy received more than 3 years ago
- Scheduled to receive chemotherapy with or without targeted therapies including immunotherapies
You will not qualify if you...
- Metastatic disease
- Receiving radiation therapy during the study
- Receiving antibiotic treatment during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before chemotherapy
Participants provide stool and blood samples and complete questionnaires to assess baseline gut microbiome and symptoms before chemotherapy.
1 visit (in-person)
Duration - 3 to 5 days after chemotherapy initiation
Participants provide a second set of stool and blood samples and complete questionnaires 3 to 5 days after starting chemotherapy to evaluate changes in gut microbiome and symptoms.
1 visit (in-person)
Trial Site Locations
Total: 5 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Suspended
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Active, Not Recruiting
3
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
Actively Recruiting
4
Mayo Clinic Health System in Mankato
Mankato, Minnesota, United States, 56001
Actively Recruiting
5
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Suspended
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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