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

Mayo Clinic

Status: Terminated

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

Treatments: Other: Blood and Tissue

Study type: Observational

Funder types: Other

Identifiers

NCT05819827

22-010340

NCI-2023-02454 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

13 participants in 1 patient group

Patients with genitourinary cancers

Description:

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.

Treatment:

Other: Blood and Tissue