Paullinia Cupana for Anorexia in Oncologic Patients

Phase 1

• Conditions: Cancer-related Problem/Condition; Anorexia; Loss of Weight
• Interventions: Drug: Paullinia cupana

• Registration Number: NCT01540019
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-04
• Status Verified: 2012-01
• Study First Submitted: 2012-01-29
• Study First Submitted QC: 2012-02-22
• Last Update Submitted: 2012-02-22
• Study First Posted: 2012-02-28
• Last Update Posted: 2012-02-28
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paullinea cupana	Paullinia cupana	50mg of Paullinia cupana as capsule, twice daily

Primary Outcome Measures

Name	Time	Method
weight	eight weeks	Patients will considered to respond to guaraná if the gain 5% or more of his inicial weight during the treatment period

Secondary Outcome Measures

Name	Time	Method
quality of life	eight weeks	Weekly patients will answer questionaries about quality of life like FACT-G

Trial Locations

Locations (1)

Faculdade de Medicina do ABC; 🇧🇷 Santo André, São Paulo, Brazil