Assessment of the Role of Bifidobacterium-Containing Food Supplement Activia™ and Bacteriomic Profiling and Other Biomarkers Associated With Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor (VEGF-TKI)-Induced Diarrhea in Patients With Metastatic Renal Cell Carcinoma (mRCC)
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · City of Hope Medical Center
interventional
21
1 country
1
Study Start
November 11, 2016
Actual (reported)Primary Completion
December 19, 2021
Actual (reported)Study Completion
December 19, 2021
Actual (reported)This randomized clinical trial studies how well probiotic yogurt supplement works in reducing diarrhea in patients with kidney cancer that has spread from the primary site to other places in the body (metastatic) and that are being treated with vascular endothelial growth factor-tyrosine kinase inhibitor therapy. Studying samples of blood and stool from patients who eat probiotic yogurt and those who avoid probiotic yogurt may help doctors plan better treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 19, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 27, 2016
Actual (reported)October 26, 2016
Actual (reported)November 11, 2016
Actual (reported)December 19, 2021
Actual (reported)December 19, 2021
Actual (reported)April 19, 2023
Actual (reported)Number of Participants With Overall Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Up to 3 years
Number of Participants With Diarrhea
The rate of all grade diarrhea as graded by the Common Terminology Criteria for Adverse Events version 4.0 will be compared in the patients who receive the dietary supplement and those who do not. A Fisher's exact test with a 0.050 one-sided significance level will be used.
Up to 13 weeks
Clinical Benefit Rate
Up to 6 months
Progression-free Survival (PFS)
Up to 36 months
Patients receive probiotic supplement Activia yogurt QD during weeks 2-13 of VEGF-TKI treatment.
Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months.
Correlative studies
Receive Activia yogurt
City of Hope Medical Center
Duarte, California, 91010, United States
Dizman N, Hsu J, Bergerot PG, Gillece JD, Folkerts M, Reining L, Trent J, Highlander SK, Pal SK. Randomized trial assessing impact of probiotic supplementation on gut microbiome and clinical outcome from targeted therapy in metastatic renal cell carcinoma. Cancer Med. 2021 Jan;10(1):79-86. doi: 10.1002/cam4.3569. Epub 2020 Nov 1.
Sumanta Pal
City of Hope Medical Center
21 participants (actual enrollment reported by the registry).
First Submitted
July 27, 2016
First Posted
October 26, 2016
Study Start
November 11, 2016
Actual (reported)Must be received as standard of care chemotherapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 19, 2021
Actual (reported)Study Completion
December 19, 2021
Actual (reported)Last Updated
February 23, 2024
Results First Posted
April 19, 2023
Record last verified: 2024-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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