Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors

Phase 2

• Conditions: Solid Tumors
• Interventions: Drug: uncaria tomentosa (cat´s claw)

• Registration Number: NCT02045719
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. Patients and methods: This prospective phase II study will assess the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on individuals with advanced solid tumors, with no further therapeutic options and with at least 2 months life expectancy. In addition, several biochemical and inflammatory parameters will be analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-01
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-24
• Last Update Submitted: 2014-01-24
• Study First Posted: 2014-01-27
• Last Update Posted: 2014-01-27
• Primary Completion: 2014-07
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• individuals with advanced solid tumors, with no further therapeutic options and with at least 2 moths life expectancy
• individuals 18 years of age and older
• creatinine levels up to twice the upper limit of normal (ULN)
• alanine (ALT) and aspartate (ASP) transaminase levels up to twice the ULN and direct bilirubin (DB) levels up to 1.5 times the ULN
• in cases with pre-existing liver disease, the ALT, ASP and DB levels could be up to 2.5 times the ULN

Exclusion Criteria

• pregnant and breastfeeding women
• individuals using chemotherapy or other tumor-targeting antineoplastic treatments, except for antalgic radiotherapy
• severe kidney or liver failure
• known hypersensitiveness to the components of the medication used
• past history of emotional disorders that could interfere with the data collection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cat's claw	uncaria tomentosa (cat´s claw)	100 mg dose of a dry extract of U. tomentosa three times per day

Primary Outcome Measures

Name	Time	Method
assessment of benefits on quality of life after treatment during two months	two months	Assess the efficacy and safety of a dry extract of U. tomentosa on individuals who had solid tumors with no further therapeutic options

Trial Locations

Locations (1)

Centro de Estudos e Pesquisa em Hematologia e Oncologia; 🇧🇷 Santo André, São Paulo, Brazil