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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Number of Participants With Overall Response
Study Overview
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine if adding Activia yogurt (containing Bifidobacterium lactis DN-173 010) to the diet of patients with metastatic renal cell carcinoma (mRCC) increases the level of Bifidobacterium spp in stool.
SECONDARY OBJECTIVES:
I. To determine if Activia reduces the incidence of diarrhea for mRCC patients treated with vascular endothelial growth factor - tyrosine kinase inhibitor (VEGF-TKI) therapy.
II. To compare pre-treatment levels of circulating T regulatory (Treg) cells and levels of peripheral signal transducers and activators of transcription 3 (STAT3) in patients with and without diarrhea with VEGF-TKI therapy, and correlate with Bifidobacterium, other bacteria, and Activia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC)
- •Diagnosis of RCC that is defined as metastatic by standard criteria (American Joint Committee on Cancer [AJCC] 7th edition, 2010)
- •Planned treatment with any VEGF-TKI, treatment has not yet begun
- •Ability to understand and the willingness to sign a written informed consent
- •Ability to read and write English
- •Documented consent to participation to include the following study specific procedures:
- •Be able to provide up to six serial stool collections at home and deliver to FedEx location that day as per standard operating procedure
- •Have three 10-ml blood samples taken during a routine clinic visit
- •To not take probiotic supplements except as oriented
- •If randomized to the probiotic-supplemented group (the yogurt-based supplement Activia), be willing to comply with daily intake and record this intake as a component of a dietary log; the patient will be asked not to take any yogurt or yogurt-containing foods beyond this
- •If randomized to the probiotic-restricted group, agree not to consume yogurt or yogurt-containing foods
- •Maintain a dietary log and stool frequency log
Exclusion Criteria
- •Patients with a known intolerance to lactose or other constituents of Activia
- •Patients with irritable bowel syndrome, Crohn's disease, or other clinically significant gastrointestinal (GI) related condition that might confound the VEGF-TKI-related-diarrhea endpoint
- •Patients taking antibiotics or who plan to begin taking antibiotics
- •Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)
Arms & Interventions
Arm I (probiotic yogurt supplement)
Patients receive probiotic supplement Activia yogurt QD during weeks 2-13 of VEGF-TKI treatment.
Intervention: VEGF-TKI (Drug)
Arm I (probiotic yogurt supplement)
Patients receive probiotic supplement Activia yogurt QD during weeks 2-13 of VEGF-TKI treatment.
Intervention: Laboratory Biomarker Analysis (Other)
Arm I (probiotic yogurt supplement)
Patients receive probiotic supplement Activia yogurt QD during weeks 2-13 of VEGF-TKI treatment.
Intervention: Micronutrient-Fortified Probiotic Yogurt (Dietary Supplement)
Arm II (no intervention)
Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months.
Intervention: Laboratory Biomarker Analysis (Other)
Arm II (no intervention)
Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months.
Intervention: VEGF-TKI (Drug)
Outcomes
Primary Outcomes
Number of Participants With Overall Response
Time Frame: Up to 3 years
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
Number of Participants With Diarrhea
Time Frame: Up to 13 weeks
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.
Secondary Outcomes
- Clinical Benefit Rate(Up to 6 months)
- Progression-free Survival (PFS)(Up to 36 months)