Guarana (Paullinia Cupana) for Anorexia Related to Cancer
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
weight
Patients will considered to respond to guaraná if the gain 5% or more of his inicial weight during the treatment period
eight weeks
No
Claudia Latorre
Study Chair
Faculdade de Medicina do ABC
Brazil: National Committee of Ethics in Research
FaculdadeMABC
NCT01540019
April 2011
July 2013
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