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

A

ABC Foundation (FUABC)

Status and phase

Unknown
Phase 2

Conditions

Solid Tumors

Treatments

Drug: uncaria tomentosa (cat´s claw)

Study type

Interventional

Funder types

Other

Identifiers

NCT02045719
ABC2013

Details and patient eligibility

About

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.

Enrollment

51 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

51 participants in 1 patient group

cat's claw
Experimental group
Description:
100 mg dose of a dry extract of U. tomentosa three times per day
Treatment:
Drug: uncaria tomentosa (cat´s claw)

Trial contacts and locations

1

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Central trial contact

Larissa de Paula

Data sourced from clinicaltrials.gov

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