Evaluating the Association Between Changes in the Gut Microbiome and Chemotherapy-Induced Nausea in Women Receiving Chemotherapy for Stage I-III Breast Cancer
Study Details
Study Description
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 chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for stage I-III breast cancer. Patients undergoing chemotherapy may experience nausea as a result of their treatment. Known risk factors for CIN do not explain the differences in CIN occurrence between patients, but changes in the functions of the gut microbiome may be related to the occurrence of 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 CIN.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
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Evaluate the feasibility of patient recruitment and retention, as well as specimen collection.
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Estimate the effect size for changes in gut microbiome composition profiles from T1 to T2 that are associated with the occurrence of CIN.
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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 CIN.
OUTLINE:
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational (survey, 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. |
Procedure: Biospecimen Collection
Undergo collection of stool samples
Other Names:
Other: Questionnaire Administration
Complete questionnaires
|
Outcome Measures
Primary Outcome Measures
- 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 up to a total of 30 days]
Assessed using descriptive statistics.
- Number of patients who provided stool samples at both assessments [At baseline and 3-5 days after initiation of chemotherapy up to total of 30 days]
Assessed using descriptive statistics.
- Bacterial composition of stool samples [Up to study completion, up to 30 days]
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 chemotherapy-induced nausea (CIN) at T2 as measured by questionnaire, will be determined using linear discriminant analysis effect size.
- Differences in demographic between patients who do and do not report CIN [Up to study completion, up to 30 days]
The demographic characteristics will be assessed using the review of the electronic health record. Changes in the demographic characteristics in association with CIN occurrence will be evaluated using parametric and non-parametric tests.
- Differences in clinical characteristics/comorbidities between patients who do and do not report CIN [Up to study completion, up to 30 days]
Clinical characteristics will be assed using review of the electronic health record and by patient completed Self Administered Comorbidities Questionnaire, Alcohol Use Disorders Identification Test (AUDIT). Differences in clinical characteristics in association with CIN occurrence will be evaluated using parametric and non-parametric tests.
- Differences in symptoms between patients who do or do not report CIN [Up to study completion, up to 30 days]
Patient symptoms will be assessed by using the be evaluated by using the Memorial Symptom Assessment Scale, Anxiety measured by Spielberger State Trait Anxiety Inventory, Depression measured by Center for Epidemiological Studies/Depression Scale. Differences in symptom characteristics in association with CIN occurrence will be evaluated using parametric and non-parametric tests.
- Differences in diet between patients who do and do not report CIN [Up to study completion, up to 30 days]
Diet will be assessed using the NCI Dietary Screening Questionnaire (short form) only at timepoint 1. Diet in association with CIN occurrence will be evaluated using dietary software.
- Differences in exercise between patients who do and do not report CIN [Up to study completion, up to 30 days]
Exercise will be evaluated using the Exercise questionnaire used for measure. Differences in exercise characteristics in association with CIN occurrence will be evaluated using parametric and non-parametric tests.
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 20 years of age
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Chemotherapy naive
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Female gender
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Will receive taxotere + cyclophosphamide treatment +/- trastuzumab
Exclusion Criteria:
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Metastatic disease
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Concurrent radiation therapy
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Concurrent antibiotic treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Brenda J Ernst, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-009279
- NCI-2022-01231
- 20-009279
- P30CA015083