Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics
Status
RECRUITING
Phase
Age
≥ 20 Years
Enrollments
30Conditions
Bladder Cancer, Prostate Cancer, Testicular Cancer, Bladder Carcinoma, Genitourinary System Carcinoma, Malignant Testicular Neoplasm, Melanoma, Prostate Carcinoma, SarcomaSummary
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.
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Clinical Trials Referral Office
- 855-776-0015
- [email protected]
Principal Investigator
- Komal P. Singh, Ph.D., R.N.
Status
- RECRUITING
Contact Person
- Clinical Trials Referral Office
- 855-776-0015
- [email protected]
Principal Investigator
- Komal P. Singh, Ph.D., R.N.
Eligibility Criteria
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
Study Plan
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 TissueDescription:
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.nnBlood samples will be collected prior to their first chemotherapy treatment, and in the second week after chemotherapy.
Outcome Measures
Primary Outcome Measures
Change in patient recruitment
Change in patient retention
Change in patient specimen collection
Change of the gut microbiome
Associations between microbial composition functional profiles
Evaluate for differentially abundant metabolites
Evaluate for perturbed metabolic pathways
Timeline
Last Updated
May 21, 2024Start Date
April 19, 2023Today
January 16, 2025Completion Date ( Estimated )
March 27, 2025
Sponsors of this trial
Lead Sponsor
Mayo Clinic
RECRUITING 
21 - 64 Years