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

Solid Tumors Clinical Trial

— cat´sclaw  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02045719
• Other study ID #: ABC2013
• Status: Recruiting
• Phase: Phase 2
• First received: January 23, 2014
• Last updated: January 24, 2014
• Start date: December 2013
• Est. completion date: September 2014

Study information

• Verified date: January 2014
• Source: Faculdade de Medicina do ABC
• Contact: Larissa de Paula
• Phone: 5511992951626
• Email: lariclpaula[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• uncaria tomentosa (cat´s claw)

Locations

Country	Name	City	State
Brazil	Centro de Estudos e Pesquisa em Hematologia e Oncologia	Santo André	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes