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

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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Bladder Cancer; Testicular Cancer
• Intervention / Treatment: Other: Blood and Tissue

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 Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Komal P. Singh, Ph.D., R.N.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Not yet recruiting
      • Mayo Clinic
      • Contact: Clinical Trials Referral Office; Phone Number: 507-538-7623; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Cindy Tofthagen, Ph.D., R.N.
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Clinical Trials Referral Office; Phone Number: 507-266-4000; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Daniel (Dan) S. Childs, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a diagnosis of bladder cancer, prostate cancer, and testicular cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic, Arizona, Mayo Clinic Rochester, MN and Mayo Clinic Florida.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Komal P. Singh, Ph.D., R.N., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Estimated): March 27, 2025
• Study Completion (Estimated): March 27, 2025

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Testicular Neoplasms; Urogenital Neoplasms
• Other Study ID Numbers: 22-010340; NCI-2023-02454 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No