Paullinia Cupana for Anorexia in Oncologic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01540019
Recruitment Status : Unknown
Verified January 2012 by Felipe Melo Cruz, Faculdade de Medicina do ABC.
Recruitment status was:  Recruiting
First Posted : February 28, 2012
Last Update Posted : February 28, 2012
Information provided by (Responsible Party):
Felipe Melo Cruz, 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.

Condition or disease Intervention/treatment Phase
Cancer-related Problem/Condition Anorexia Loss of Weight Drug: Paullinia cupana Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Guarana (Paullinia Cupana) for Anorexia Related to Cancer
Study Start Date : April 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Paullinea cupana
50mg of Paullinia cupana as capsule, twice daily
Drug: Paullinia cupana
50mg of Paullinia cupana as capsule, twice daily

Primary Outcome Measures :
  1. weight [ Time Frame: 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 :
  1. quality of life [ Time Frame: eight weeks ]
    Weekly patients will answer questionaries about quality of life like FACT-G

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01540019

Faculdade de Medicina do ABC Recruiting
Santo André, São Paulo, Brazil, 09060-650
Contact: Claudia Latorre    55117717-3241   
Sponsors and Collaborators
Faculdade de Medicina do ABC
Study Chair: Claudia Latorre Faculdade de Medicina do ABC

Responsible Party: Felipe Melo Cruz, MsC, Faculdade de Medicina do ABC Identifier: NCT01540019     History of Changes
Other Study ID Numbers: FaculdadeMABC
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: January 2012

Keywords provided by Felipe Melo Cruz, Faculdade de Medicina do ABC:
Paullinia cupana
loss of weight

Additional relevant MeSH terms:
Weight Loss
Signs and Symptoms, Digestive
Signs and Symptoms
Body Weight Changes
Body Weight