NCT05819827

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-19
• Primary completion: 2024-05-21
• Completion: 2024-05-21
• First posted: 2023-04-19
• Last updated: 2025-04-27

Locations

3 sites across 1 country: United States