Status:
COMPLETED
Fecal Microbiota Transplantation in Diarrhea Induced by Tyrosine-kinase Inhibitors
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Diarrhea Caused by Drug (Disorder)
Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Tyrosine kinase inhibitors (TKIs) have improved the survival of patients with metastatic renal cell carcinoma, and are commonly used as first-line option for this condition, but their use is encumbere...
Detailed Description
Despite the improvement in diagnosis and management, renal cell carcinoma (RCC) remains one of the most burdensome urological cancers, being the sixth most common malignancy in men and the 10th in wom...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18 years old or older
- treatment with pazopanib or sunitinib for metastatic RCC diagnosed at histology and measurable according to RECIST criteria version 1.1
- development of diarrhea of 2-3 grade according to Common Terminology Criteria (CTC) for Adverse Events (AE) version 4.0 induced by these drugs.
- execution of a CT scan no earlier than 4 weeks before enrollment
- good or intermediate prognostic assessment (according to criteria of the prognostic system of the International Metastatic RCC Database Consortium)
- performance status equal or lower than 2
- blood count, hepatic and kidney testing within normal limit
- ability to give their consent to be included in the study.
- Exclusion criteria:
- another known cause of diarrhea (e.g. infectious gastroenteritis. Clostridium difficile infection, celiac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhea)
- previous colorectal surgery or cutaneous stoma
- food allergies
- recent (\<6 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antibiotics, probiotics, proton pump inhibitors, immunosuppressants, metformin)
- another cancer (except for surgically treated basocellular carcinoma)
- brain metastases
- decompensated heart failure or heart disease with ejection fraction lower than 30%
- severe respiratory insufficiency
- psychiatric disorders
- pregnancy
- unable to give informed consent.
Exclusion
Key Trial Info
Start Date :
August 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04040712
Start Date
August 2 2019
End Date
February 5 2020
Last Update
March 17 2020
Active Locations (1)
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1
Fondazione Policlinico Universitario "A. Gemelli" IRCCS
Rome, Italy, 00168