Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw)... | NCT02045719

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

NCT02045719

Sponsor

Faculdade de Medicina do ABC

Status

Unknown status

Last Update Posted

Jan 27, 2014Estimated

Enrollment

51Estimated

Phase

Phase 2

Conditions

Solid Tumors

Interventions

uncaria tomentosa (cat´s claw)

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Jul 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Jan 23, 2014

First Submission Date that Met QC Criteria

Jan 24, 2014

First Posted Date

Jan 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2014

Last Update Posted Date

Jan 27, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
uncaria tomentosa (cat´s claw)	Drug		cat's claw	100 mg dose of a dry extract of U. tomentosa three times per day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Larissa de Paula	Contact	5511992951626		lariclpaula@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro de Estudos e Pesquisa em Hematologia e Oncologia	Recruiting	Santo André	São Paulo	09060-650	Brazil

Intervention Browse Module

MeSH Terms

ID	Term
C000713767	cat's claw extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided