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

N/ATerminatedNCT05819827

Mayo Clinic13 enrolled

Overview

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

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

Conditions

Bladder Cancer Prostate Cancer Testicular Cancer Bladder Carcinoma Genitourinary System Carcinoma Malignant Testicular Neoplasm Melanoma

Interventions

Blood and TissueOTHER

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (3)

Mayo Clinic

Scottsdale, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: Up to 10 months