Probiotic Yogurt Supplement in Reducing Diarrhea in Patients With Metastatic Kidney Cancer Being Treated With Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitor

NCT02944617 | Completed Results DMC

• 2 other identifiers: 16088NCI-2016-01068
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Metastatic Renal Cell Carcinoma; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Clinical Benefit Rate

  Up to 6 months

• Progression-free Survival (PFS)

  Up to 36 months

Study Arms (2)

Arm I (probiotic yogurt supplement)

EXPERIMENTAL

Patients receive probiotic supplement Activia yogurt QD during weeks 2-13 of VEGF-TKI treatment.

Other: Laboratory Biomarker Analysis; Dietary Supplement: Micronutrient-Fortified Probiotic Yogurt; Drug: VEGF-TKI

Arm II (no intervention)

ACTIVE COMPARATOR

Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months.

Other: Laboratory Biomarker Analysis; Drug: VEGF-TKI

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (probiotic yogurt supplement); Arm II (no intervention)

Micronutrient-Fortified Probiotic Yogurt DIETARY_SUPPLEMENT

Receive Activia yogurt

Arm I (probiotic yogurt supplement)

VEGF-TKI DRUG

Must be received as standard of care chemotherapy

Arm I (probiotic yogurt supplement); Arm II (no intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

• 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.

  PMID: 33135866 DERIVED

MeSH Terms

Conditions

Diarrhea; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-218-5265

Study Officials

• Sumanta Pal

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: October 26, 2016
• Study Start: November 11, 2016
• Primary Completion: December 19, 2021
• Study Completion: December 19, 2021
• Last Updated: February 23, 2024
• Results First Posted: April 19, 2023

Record last verified: 2024-01

Locations

US (1)