Overview

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

Status:
Unknown status
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Faculdade de Medicina do ABC
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.