Trial Outcomes & Findings for Probiotic Yogurt Supplement in Reducing Diarrhea in Patients With Metastatic Kidney Cancer Being Treated With Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitor (NCT NCT02944617)

NCT ID: NCT02944617

Last Updated: 2024-02-23

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2024-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Probiotic Yogurt Supplement) Patients receive 4 oz. probiotic supplement Activia yogurt bid during weeks 2-13 and refrain from taking/consuming other probiotic supplements. Micronutrient-Fortified Probiotic Yogurt: Receive Activia yogurt VEGF-TKI: Must be received as standard of care chemotherapy	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. Laboratory Biomarker Analysis: Correlative studies VEGF-TKI: Must be received as standard of care chemotherapy
Overall Study STARTED	11	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Probiotic Yogurt Supplement) n=10 Participants Patients receive 4 oz. probiotic supplement Activia yogurt bid during weeks 2-13 and refrain from taking/consuming other probiotic supplements. Micronutrient-Fortified Probiotic Yogurt: Receive Activia yogurt VEGF-TKI: Must be received as standard of care chemotherapy	Arm II (no Intervention) n=10 Participants Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months. Laboratory Biomarker Analysis: Correlative studies VEGF-TKI: Must be received as standard of care chemotherapy	Total n=20 Participants Total of all reporting groups
Age, Continuous	67.0 years n=10 Participants	67.5 years n=10 Participants	67.5 years n=20 Participants
Sex: Female, Male Female	2 Participants n=10 Participants	3 Participants n=10 Participants	5 Participants n=20 Participants
Sex: Female, Male Male	8 Participants n=10 Participants	7 Participants n=10 Participants	15 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	10 participants n=10 Participants	20 participants n=20 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Arm I (Probiotic Yogurt Supplement) n=10 Participants Patients receive 4 oz. probiotic supplement Activia yogurt bid during weeks 2-13 and refrain from taking/consuming other probiotic supplements. Micronutrient-Fortified Probiotic Yogurt: Receive Activia yogurt VEGF-TKI: Must be received as standard of care chemotherapy	Arm II (no Intervention) n=10 Participants Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months. Laboratory Biomarker Analysis: Correlative studies VEGF-TKI: Must be received as standard of care chemotherapy
Number of Participants With Overall Response	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm I (Probiotic Yogurt Supplement) n=10 Participants Patients receive 4 oz. probiotic supplement Activia yogurt bid during weeks 2-13 and refrain from taking/consuming other probiotic supplements. Micronutrient-Fortified Probiotic Yogurt: Receive Activia yogurt VEGF-TKI: Must be received as standard of care chemotherapy	Arm II (no Intervention) n=10 Participants Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months. Laboratory Biomarker Analysis: Correlative studies VEGF-TKI: Must be received as standard of care chemotherapy
Number of Participants With Diarrhea	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 6 months

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): At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR; Stable disease (SD): Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD; Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). Clinical Benefit Rate (CBR) = CR + PR + SD at 6 months

Outcome measures

Outcome measures
Measure	Arm I (Probiotic Yogurt Supplement) n=10 Participants Patients receive 4 oz. probiotic supplement Activia yogurt bid during weeks 2-13 and refrain from taking/consuming other probiotic supplements. Micronutrient-Fortified Probiotic Yogurt: Receive Activia yogurt VEGF-TKI: Must be received as standard of care chemotherapy	Arm II (no Intervention) n=10 Participants Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months. Laboratory Biomarker Analysis: Correlative studies VEGF-TKI: Must be received as standard of care chemotherapy
Clinical Benefit Rate	70 percentage of participants	80 percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Estimated using the product-limit method of Kaplan and Meier. Failure defined as disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Arm I (Probiotic Yogurt Supplement) n=10 Participants Patients receive 4 oz. probiotic supplement Activia yogurt bid during weeks 2-13 and refrain from taking/consuming other probiotic supplements. Micronutrient-Fortified Probiotic Yogurt: Receive Activia yogurt VEGF-TKI: Must be received as standard of care chemotherapy	Arm II (no Intervention) n=10 Participants Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months. Laboratory Biomarker Analysis: Correlative studies VEGF-TKI: Must be received as standard of care chemotherapy
Progression-free Survival (PFS)	6.2 Months Interval 2.2 to 10.3	13.8 Months Interval 6.2 to 21.5

Adverse Events

Arm I (Probiotic Yogurt Supplement)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 3 deaths

Arm II (no Intervention)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I (Probiotic Yogurt Supplement) n=10 participants at risk Patients receive 4 oz. probiotic supplement Activia yogurt bid during weeks 2-13 and refrain from taking/consuming other probiotic supplements. Micronutrient-Fortified Probiotic Yogurt: Receive Activia yogurt VEGF-TKI: Must be received as standard of care chemotherapy	Arm II (no Intervention) n=10 participants at risk Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months. Laboratory Biomarker Analysis: Correlative studies VEGF-TKI: Must be received as standard of care chemotherapy
Investigations Transaminitis	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	0.00% 0/10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
General disorders Hypertension	0.00% 0/10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	20.0% 2/10 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
Immune system disorders Hand-foot Syndrome	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	20.0% 2/10 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
General disorders Sinusitis	0.00% 0/10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
General disorders Mucositis	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	20.0% 2/10 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
Endocrine disorders Hypothyroidism	0.00% 0/10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
General disorders Fatigue	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	0.00% 0/10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
Gastrointestinal disorders Gastritis	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	0.00% 0/10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
Gastrointestinal disorders Colitis	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	20.0% 2/10 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
General disorders Epistaxis	0.00% 0/10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
Skin and subcutaneous tissue disorders Dermatitis	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	0.00% 0/10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
Gastrointestinal disorders Constipation	10.0% 1/10 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	0.00% 0/10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.
Gastrointestinal disorders Diarhea	40.0% 4/10 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.	40.0% 4/10 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 4 months.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place