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

NCT02045719 | Unknown Phase 2

• 1 other identifier: ABC2013
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

cat´s claw; uncaria tomentosa; quality of life; no further therapeutic options

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

cat's claw

EXPERIMENTAL

100 mg dose of a dry extract of U. tomentosa three times per day

Drug: uncaria tomentosa (cat´s claw)

Interventions

uncaria tomentosa (cat´s claw) DRUG

Also known as: 100 mg dose of a dry extract of U. tomentosa three times per day

cat's claw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculdade de Medicina do ABC: lead

Study Sites (1)

Centro de Estudos e Pesquisa em Hematologia e Oncologia

Santo André, São Paulo, 09060-650, Brazil

RECRUITING

MeSH Terms

Interventions

cat's claw extract

Central Study Contacts

Larissa de Paula

CONTACT

5511992951626; lariclpaula@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MsC

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: December 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 27, 2014

Record last verified: 2014-01

Locations

BR (1)