Investigation of Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary Cancer and Changes in Gut Microbiome: Potential for Precision Therapeutics
Study Details
Study Description
Brief Summary
The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with genitourinary cancers 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
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.
|
Outcome Measures
Primary Outcome Measures
- Analyze patient recruitment [Up to 14 days]
Evaluate the feasibility of patient recruitment by using descriptive statistics to determine number of patients approached
- Analyze patient retention [Up to 14 days]
Evaluate the feasibility of patient retention by using descriptive statistics to determine number of patients who completed the questionnaires at both assessments.
- Analyze patient specimen collection [Up to 14 days]
Evaluate the feasibility of patient specimen collection by using descriptive statistics to determine number patients who provided stool samples at both assessments.
- Evaluate for changes of the gut microbiome [Up to 10 months]
Evaluate for changes in alpha and beta diversity as well as composition of the gut microbiome from T1 to T2 in patients who do and do not report CIN at T2. V3-V5 region of the 16s rRNA gene will be targeted for sequencing and submitted to trimmomatic for reads trimming and quality control.
- Examine associations between microbial composition functional profiles [Up to 10 months]
Examine associations between microbial composition functional profiles at T1 and T2 in patients who report CIN at T2. Change in relative abundance of genus associated with CIN occurrence will used to predict the function of the genus. To perform functional profiling, we will use PiCrust.
- Evaluate for differentially abundant metabolites [Up to 10 months]
Evaluate for differentially abundant metabolites associated with microbiome diversity in patients who do and do not report CIN occurrence at T2. Metabolomics profiling of stool samples at T1 and T2 using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
- Evaluate for perturbed metabolic pathways [Up to 10 months]
Evaluate for perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report CIN occurrence at T2. Metabolomics profiling of stool samples at T1 and T2 using liquid chromatography-tandem mass spectrometry (LC-MS/MS), as well as RNA-Seq analyses.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
at least 20 years of age
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last chemotherapy more than 3 years ago
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scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies
Exclusion Criteria:
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concurrent radiation therapy
-
concurrent antibiotic treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Jacksonville | Florida | United States | 32224-9980 |
| 2 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 3 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Komal P. Singh, Ph.D., R.N., Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-010340