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Trial Title:
Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics
NCT ID:
NCT05819827
Condition:
Bladder Cancer
Prostate Cancer
Testicular Cancer
Bladder Carcinoma
Genitourinary System Carcinoma
Malignant Testicular Neoplasm
Melanoma
Prostate Carcinoma
Sarcoma
Conditions: Official terms:
Carcinoma
Melanoma
Sarcoma
Urinary Bladder Neoplasms
Testicular Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood and Tissue
Description:
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.
Arm group label:
Patients with genitourinary cancers
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Komal P. Singh, Ph.D., R.N.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Cindy Tofthagen, Ph.D., R.N.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Daniel (Dan) S. Childs, M.D.
Email:
Principal Investigator
Start date:
April 19, 2023
Completion date:
March 27, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05819827
https://www.mayo.edu/research/clinical-trials
