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

January 24, 2014 updated by: Felipe Melo Cruz, Faculdade de Medicina do ABC
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-650
        • Recruiting
        • Centro de Estudos e Pesquisa em Hematologia e Oncologia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Medicina do ABC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABC2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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