Breast Cancer Clinical Trial
Evaluating the Association Between Changes in the Gut Microbiome and Chemotherapy-Induced Nausea in Women Receiving Chemotherapy for Stage I-III Breast Cancer
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.
Full 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 from T1 to T2 that are associated with the occurrence of 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 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.
Eligibility Criteria
Inclusion Criteria:
At least 20 years of age
Chemotherapy naive
Female gender
Will receive taxotere + cyclophosphamide treatment +/- trastuzumab
Exclusion Criteria:
Metastatic disease
Concurrent radiation therapy
Concurrent antibiotic treatment
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There is 1 Location for this study
Scottsdale Arizona, 85259, United States More Info
Principal Investigator
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