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

NCT05819827 | Terminated

• 2 other identifiers: 22-010340NCI-2023-02454
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

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

Interventions

Blood and Tissue OTHER

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.

Patients with genitourinary cancers

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• concurrent radiation therapy
• concurrent antibiotic treatment
• concurrent oncolytic virus treatment

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

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. The blood sample will be used for several assays that include gene expression, immune cell profiling, metabolite analytics, and additional omics assays.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Prostatic Neoplasms; Testicular Neoplasms; Melanoma; Sarcoma

Interventions

Blood Specimen Collection; Histocompatibility Testing

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Immunologic Tests; Immunologic Techniques

Study Officials

• Komal P. Singh, Ph.D., R.N.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: April 19, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (3)