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

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.

Study Overview

• Status: Unknown
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: uncaria tomentosa (cat´s claw)

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Santo André, São Paulo, Brazil, 09060-650
      • Recruiting
      • Centro de Estudos e Pesquisa em Hematologia e Oncologia
      • Contact: Larissa de Paula; Phone Number: 55992951626; Email: lariclpaula@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cat's claw; 100 mg dose of a dry extract of U. tomentosa three times per day	Drug: uncaria tomentosa (cat´s claw); Other Names: 100 mg dose of a dry extract of U. tomentosa three times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of benefits on quality of life after treatment during 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	two months

Collaborators and Investigators

• Sponsor: Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: January 24, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Estimate): January 27, 2014
• Last Update Submitted That Met QC Criteria: January 24, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: quality of life; cat´s claw; uncaria tomentosa; no further therapeutic options
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ABC2013