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

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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

Tracking Information
First Submitted Date  ICMJE January 23, 2014
First Posted Date  ICMJE January 27, 2014
Last Update Posted Date January 27, 2014
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2014)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors
Official Title  ICMJE Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Solid Tumors
Intervention  ICMJE Drug: uncaria tomentosa (cat´s claw)
Other Name: 100 mg dose of a dry extract of U. tomentosa three times per day
Study Arms  ICMJE Experimental: cat's claw
100 mg dose of a dry extract of U. tomentosa three times per day
Intervention: Drug: uncaria tomentosa (cat´s claw)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 24, 2014)		 51
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02045719
Other Study ID Numbers  ICMJE ABC2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Felipe Melo Cruz, Faculdade de Medicina do ABC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Faculdade de Medicina do ABC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Faculdade de Medicina do ABC
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP