Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo collection of stool and blood samples and complete questionnaires on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of stool and blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients approached | Assessed using descriptive statistics. | Up to 24 months |
| Number of patients enrolled | Assessed using descriptive statistics. | Up to 24 months |
| Number of patients who completed the questionnaires at both assessments | Assessed using descriptive statistics. | At baseline and 3-5 days after initiation of chemotherapy |
| Number of patients who provided stool samples at both assessments | Assessed using descriptive statistics. | 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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, Minnesota, and Mayo Clinic Florida.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brenda J. Ernst, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Suspended | Scottsdale | Arizona | 85259 | United States | |
| Mayo Clinic in Florida |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionnaire Administration | Other | Complete questionnaires |
|
| 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. | 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. | Up to study completion |
| Active, not recruiting |
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Mayo Clinic Health System in Albert Lea | Recruiting | Albert Lea | Minnesota | 56007 | United States |
|
| Mayo Clinic Health System in Mankato | Recruiting | Mankato | Minnesota | 56001 | United States |
|
| Mayo Clinic in Rochester | Suspended | Rochester | Minnesota | 55905 | United States |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided