Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles
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.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo collection of stool and blood samples
- OtherQuestionnaire Administration
Complete questionnaires
Outcome measures
Primary
Number of patients approached
Assessed using descriptive statistics.
Time frame: Up to 24 months
Number of patients enrolled
Assessed using descriptive statistics.
Time frame: Up to 24 months
Number of patients who completed the questionnaires at both assessments
Assessed using descriptive statistics.
Time frame: At baseline and 3-5 days after initiation of chemotherapy
Number of patients who provided stool samples at both assessments
Assessed using descriptive statistics.
Time frame: At baseline and 3-5 days after initiation of chemotherapy
Bacterial composition of stool samples
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.
Time frame: Up to study completion
Differences in demographic between patients who do and do not report fatigue and CIN
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.
Time frame: Up to study completion
Differences in clinical characteristics between patients who do and do not report CIN
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.
Time frame: Up to study completion
Differences in comorbidities between patients who do and do not report CIN
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.
Time frame: Up to study completion
Eligibility criteria
Study locations (5)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Mayo Clinic Health System in Mankato
Mankato, Minnesota, 56001
Mayo Clinic in Rochester
Rochester, Minnesota, 55905