Evaluating the Association Between Changes in the Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer
- Conditions
- Chemotherapy-Related Nausea And/or VomitingAnatomic Stage I Breast Cancer AJCC V8Early Stage Breast CarcinomaAnatomic Stage II Breast Cancer AJCC V8
- Interventions
- Procedure: Biospecimen CollectionOther: Questionnaire Administration
- Registration Number
- NCT05417867
- Lead Sponsor
- Mayo Clinic
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- Metastatic disease
- Concurrent radiation therapy
- Concurrent antibiotic treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational (survey, biospecimen collection) Questionnaire Administration Patients undergo collection of stool samples over 10 minutes and complete questionnaires over 60 minutes at baseline and 3-5 days following initiation of standard of care chemotherapy. Observational (survey, biospecimen collection) Biospecimen Collection Patients undergo collection of stool samples over 10 minutes and complete questionnaires over 60 minutes at baseline and 3-5 days following initiation of standard of care chemotherapy.
- Primary Outcome Measures
Name Time Method Number of patients approached Up to 24 months Assessed using descriptive statistics.
Number of patients enrolled Up to 24 months Assessed using descriptive statistics.
Number of patients who completed the questionnaires at both assessments At baseline and 3-5 days after initiation of chemotherapy Assessed using descriptive statistics.
Number of patients who provided stool samples at both assessments At baseline and 3-5 days after initiation of chemotherapy Assessed using descriptive statistics.
Bacterial composition of stool samples Up to study completion All stool samples will be processed for deoxyribonucleic acid extraction. The hypervariable regions V3 and V4 of the bacterial 16S ribosomal ribonucleic acid (rRNA) gene will be sequenced to determine bacterial composition. After quality control, 16S rRNA reads will be analyzed to determine operational taxonomic units (OTU) for T1 and T2 samples using QIIME software. Alpha (within sample) diversity and beta (between sample) diversity will be analyzed using nonmetric multidimensional scaling ordination and the effect size for changes in OTUs in gut microbiome composition profiles from T1 to T2 in patients who do and do not report fatigue or chemotherapy-induced nausea (CIN) at T2 as measured by questionnaire.
Differences in demographic between patients who do and do not report fatigue and CIN Up to study completion Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of fatigue and CIN will be evaluated.
Differences in clinical characteristics between patients who do and do not report CIN Up to study completion Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated.
Differences in comorbidities between patients who do and do not report CIN Up to study completion Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic Health System in Mankato
🇺🇸Mankato, Minnesota, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Health System in Albert Lea
🇺🇸Albert Lea, Minnesota, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States