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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05819827
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Komal P. Singh, Ph.D., R.N.
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Bladder Cancer, Prostate Cancer, Testicular Cancer, Bladder Carcinoma, Genitourinary System Carcinoma, Malignant Testicular Neoplasm, Melanoma, Prostate Carcinoma, Sarcoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic

Scottsdale, Arizona, 85259

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

Mayo Clinic, Jacksonville, Florida

Status

Not yet recruiting

Address

Mayo Clinic

Jacksonville, Florida, 32224-9980

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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