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Paullinia Cupana for Anorexia in Oncologic Patients

NCT ID: NCT01540019

Last Updated: 2012-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-07-31

Brief Summary

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Denutrition, lost of weight and anorexia are present in many oncologic patients at any time of the disease. Anorexia is the spontaneous loss of appetite and many changes in the metabolism are made in this case, leading to this syndrome called anorexia-cachexia, that includes changes in the tumoral response and inflammatory pathways. The guaraná (Paullinia cupana) is originally from Brazil and Venezuela and has been used culturally for headaches, muscle pains, depression and others. As it has shown a good response and tolerability for fatigue, the investigators decide to try guaraná for anorexia. Patients will receive guaraná as capsules of 50 mg twice daily, for 4 weeks, and will be weighted and respond questionaries about quality of life.

Detailed Description

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Patients 18 years and older, diagnosed with any cancer, that is losing weight and have anorexia will be selected. They must have normal levels of creatinine, thyroid evaluation and hepatic function. If they are taking corticosteroid, they must keep losing weight and refer anorexia, as well as if they are on treatment with chemotherapy.

Patients will receive 50mg of the guaraná twice daily for 4 weeks. Every week will be an evaluation of the weight, level of appetite and answer 2 questionaries of quality of life and level of symptoms (FACT-G and MDASI).

This is a fase II study, open-label, no randomized, with two steps following ¨two stages of Simon¨ model. First step 18 patients will be included and if there are 3 good responses second step will follow, including 17 more patients. Response will be considered if there is at least 5% of gain in the weight.

Conditions

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Cancer-related Problem/Condition Anorexia Loss of Weight

Keywords

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anorexia Paullinia cupana loss of weight

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paullinea cupana

50mg of Paullinia cupana as capsule, twice daily

Group Type EXPERIMENTAL

Paullinia cupana

Intervention Type DRUG

50mg of Paullinia cupana as capsule, twice daily

Interventions

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Paullinia cupana

50mg of Paullinia cupana as capsule, twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adults (18 years old and older)
* palliative care or oncologic treatment
* loss of weight
* anorexia

Exclusion Criteria

* gastrointestinal obstruction
* blood pressure not controlled
* diabetes not treated
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Medicina do ABC

OTHER

Sponsor Role lead

Responsible Party

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Felipe Melo Cruz

MsC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Latorre

Role: STUDY_CHAIR

Faculdade de Medicina do ABC

Locations

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Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Claudia Latorre

Role: primary

Other Identifiers

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FaculdadeMABC

Identifier Type: -

Identifier Source: org_study_id