Clinical trial · Observational
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
NCT05819827CI-TRIAL-00088964terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low/slow accrual
Summary
Brief summary (as posted)
The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Genitourinary System Carcinoma | Genitourinary System Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Testicular Neoplasm | Malignant Testicular Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and Tissue | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with genitourinary cancers
- description
- 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.
- interventionNames
- Other: Blood and Tissue
Primary outcomes (7)
- measure
- Change in patient recruitment
- timeFrame
- Baseline, 14 days
- description
- Evaluate the feasibility of patient recruitment by using descriptive statistics to determine number of patients approached and number of patients enrolled.
- measure
- Change in patient retention
- timeFrame
- Baseline, 14 days
- description
- Evaluate the feasibility of patient retention by using descriptive statistics to determine number of patients who completed the questionnaires at both assessments.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.