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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02045719
Recruitment Status : Unknown
Verified January 2014 by Felipe Melo Cruz, Faculdade de Medicina do ABC.
Recruitment status was:  Recruiting
First Posted : January 27, 2014
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Felipe Melo Cruz, Faculdade de Medicina do ABC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: uncaria tomentosa (cat´s claw) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors
Study Start Date : December 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 100 mg dose of a dry extract of U. tomentosa three times per day


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045719


Contacts
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Contact: Larissa de Paula 5511992951626 lariclpaula@hotmail.com

Locations
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Brazil
Centro de Estudos e Pesquisa em Hematologia e Oncologia Recruiting
Santo André, São Paulo, Brazil, 09060-650
Contact: Larissa de Paula    55992951626    lariclpaula@hotmail.com   
Sponsors and Collaborators
Faculdade de Medicina do ABC
More Information
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Responsible Party: Felipe Melo Cruz, MsC, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT02045719    
Other Study ID Numbers: ABC2013
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014
Keywords provided by Felipe Melo Cruz, Faculdade de Medicina do ABC:
cat´s claw
uncaria tomentosa
quality of life
no further therapeutic options
Additional relevant MeSH terms:
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Neoplasms