Clinical trial NCT05819827: Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics
Official title: Investigation of Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bladder Cancer
Prostate Cancer
Testicular Cancer
Bladder Carcinoma
Genitourinary System Carcinoma
Malignant Testicular Neoplasm
Melanoma
Prostate Carcinoma
Sarcoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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

Primary outcomes:
measure: Change in patient recruitment
timeFrame: Baseline, 14 days
measure: Change in patient retention
timeFrame: Baseline, 14 days
measure: Change in patient specimen collection
timeFrame: Baseline, 14 days
measure: Change of the gut microbiome
timeFrame: Up to 10 months
measure: Associations between microbial composition functional profiles
timeFrame: Up to 10 months
measure: Evaluate for differentially abundant metabolites
timeFrame: Up to 10 months
measure: Evaluate for perturbed metabolic pathways
timeFrame: Up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Komal P. Singh, Ph.D., R.N.
role: PRINCIPAL_INVESTIGATOR
References: