Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary Cancer and Changes in Gut Microbiome

Study Overview
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Brief Summary
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The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.

Detailed Description
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The long-term goal of this study is to alleviate the occurrence of CIN and to improve chemotherapy treatment outcomes. The identification of associations between CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie CIN. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate CIN.

Official Title
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Investigation of Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary Cancer and Changes in Gut Microbiome: Potential for Precision Therapeutics

Conditions
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Bladder Cancer, Prostate Cancer, Testicular Cancer

Intervention / Treatment
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* Other: Blood and Tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: concurrent radiation therapy concurrent antibiotic treatment

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with genitourinary cancers<br>Genitourinary medical oncologists and study coordinators will identify patients with genitourinary cancers (i.e., bladder cancer, prostate cancer, and testicular cancer) who will receive moderate to high emetogenic chemotherapy regimen. | Other: Blood and Tissue<br>* Patients will collect stool for microbiome analysis at baseline (i.e., 3 +2 days prior to chemotherapy) and again 5-7 days following initiation of chemotherapy. Blood samples will be collected prior to their first chemotherapy treatment, and in the second week after chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associations between microbial composition functional profiles | Examine associations between microbial composition functional profiles pre- and post-chemotherapy in patients who report chemotherapy-induced nausea (CIN) after chemotherapy. Change in relative abundance of genus associated with CIN occurrence will be used to predict the function of the genus. We will use PiCrust to perform functional profiling. | Up to 10 months | 
| Evaluate for differentially abundant metabolites | Evaluate for differentially abundant metabolites associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling of stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS). | Up to 10 months | 
| Evaluate for perturbed metabolic pathways | Evaluate for perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling will be performed on stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS), as well as RNA-Seq analyses. | Up to 10 months | 
| Change in patient recruitment | Evaluate the feasibility of patient recruitment by using descriptive statistics to determine number of patients approached and number of patients enrolled. | Baseline, 14 days | 
| Change in patient retention | Evaluate the feasibility of patient retention by using descriptive statistics to determine number of patients who completed the questionnaires at both assessments. | Baseline, 14 days | 
| Change in patient specimen collection | Evaluate the feasibility of patient specimen collection by using descriptive statistics to determine number patients who provided stool samples at both assessments. | Baseline, 14 days | 
| Change of the gut microbiome | Evaluate for changes in alpha and beta diversity as well as composition of the gut microbiome pre- and post-chemotherapy in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Region V3-V5 of the 16s rRNA gene will be targeted for sequencing and submitted to trimmomatic for reads trimming and quality control. | Up to 10 months |