VEGF-TKI for Diarrhea

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diarrhea+4 More
VEGF-TKI - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether probiotic yogurt can help reduce diarrhea in people with metastatic kidney cancer who are taking VEGF-TKI therapy. Blood and stool samples will be studied to see if probiotic yogurt is a helpful treatment.

Eligible Conditions
  • Diarrhea
  • Metastatic Renal Cell Carcinoma ( mRCC)
  • Stage IV Renal Cell Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 2.5 years

Baseline
Levels of Bifidobacterium spp
Week 13
Change in levels of Bifidobacterium spp assessed in stool samples
Change in psychosocial (anxiety and depression) symptoms as measured by the Generalized Anxiety Disorder (GAD)-7 and Patient Health Questionnaire for Depression (PHQ)-9 questionnaires
Up to 13 weeks
Feasibility of bacteriomic profiling measured by viable bacteriomic profile results
Feasibility of stool collection measured by compliance with specimen submission
Incidence of diarrhea as graded by the Common Terminology Criteria for Adverse Events version 4.0
Levels of circulating Treg cells assessed in peripheral blood mononuclear cells (PMBCs)
Peripheral blood mononuclear cell (cell)
Up to 2.5 years
Gene Expression Profiling
Operational taxonomic units (OTUs) with summary of bacteriomic profiles
Short read sequences

Trial Safety

Trial Design

2 Treatment Groups

Arm II (no intervention)
1 of 2
Arm I (probiotic yogurt supplement)
1 of 2
Active Control
Experimental Treatment

21 Total Participants · 2 Treatment Groups

Primary Treatment: VEGF-TKI · No Placebo Group · N/A

Arm I (probiotic yogurt supplement)Experimental Group · 3 Interventions: VEGF-TKI, Micronutrient-Fortified Probiotic Yogurt, Laboratory Biomarker Analysis · Intervention Types: Drug, DietarySupplement, Other
Arm II (no intervention)ActiveComparator Group · 2 Interventions: VEGF-TKI, Laboratory Biomarker Analysis · Intervention Types: Drug, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2.5 years

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
505 Previous Clinical Trials
2,249,006 Total Patients Enrolled
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,867 Total Patients Enrolled
18 Trials studying Diarrhea
2,488 Patients Enrolled for Diarrhea
Sumanta PalPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
39 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have three blood samples taken during a routine clinic visit.
You have a diagnosis of renal cell carcinoma that is metastatic by standard criteria.
You are willing to comply with daily intake and record this intake as a component of a dietary log.
You have a cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.