Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics

Prostate Cancer Clinical Trial

Official title:

Investigation of Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819827
• Other study ID #: 22-010340
• Secondary ID: NCI-2023-02454
• Status: Recruiting
• Start date: April 19, 2023
• Est. completion date: March 27, 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 27, 2025
• Est. primary completion date: March 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• at least 20 years of age

• last chemotherapy more than 3 years ago

• scheduled to receive either moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies) or immunotherapies/targeted therapies alone that can lead to toxicity symptoms for example, nausea and fatigue.

• Patients receiving chemotherapy and/or immunotherapy treatment at a Mayo Clinic infusion center or an infusion center outside of Mayo Clinic

Exclusion Criteria:

• concurrent radiation therapy

• concurrent antibiotic treatment

• concurrent oncolytic virus treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Carcinoma
• Carcinoma
• Genitourinary System Carcinoma
• Malignant Testicular Neoplasm
• Melanoma
• Prostate Cancer
• Prostate Carcinoma
• Sarcoma
• Testicular Cancer
• Testicular Neoplasms
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials