Evaluating the Association Among Changes in Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Chemotherapy-Related Nausea and/or Vomiting, Early Stage Breast Carcinoma, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles
Overview
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.
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 and metabolites in stool as well as blood from time of first stool sample collection prior to chemotherapy (T1) to time of second stool sample collection after chemotherapy (T2) that are associated with the occurrence of fatigue and CIN.
III. Evaluate associations between patient reported demographic and clinical characteristics, comorbidities at T1, and changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 with the occurrence of fatigue and CIN.
OUTLINE: This is an observational study.
Patients undergo collection of stool and blood samples and complete questionnaires on study.
Interventions
- Procedure Biospecimen Collection
Undergo collection of stool and blood samples - Other Questionnaire Administration
Complete questionnaires
Primary outcome measures
- Number of patients approached [Time frame: Up to 24 months]
- Number of patients enrolled [Time frame: Up to 24 months]
- Number of patients who completed the questionnaires at both assessments [Time frame: At baseline and 3-5 days after initiation of chemotherapy]
- Number of patients who provided stool samples at both assessments [Time frame: At baseline and 3-5 days after initiation of chemotherapy]
- Bacterial composition of stool samples [Time frame: Up to study completion]
- Differences in demographic between patients who do and do not report fatigue and CIN [Time frame: Up to study completion]
- Differences in clinical characteristics between patients who do and do not report CIN [Time frame: Up to study completion]
- Differences in comorbidities between patients who do and do not report CIN [Time frame: Up to study completion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 5 centers
- Mayo Clinic in Arizona — Scottsdale
- Mayo Clinic in Florida — Jacksonville
- Mayo Clinic Health System in Albert Lea — Albert Lea
- Mayo Clinic Health System in Mankato — Mankato
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05417867 · 20-009279