Paullinia Cupana for Anorexia in Oncologic Patients

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Estado

Patrocinadores

Faculdade de Medicina do ABC

ENSAYO CLÍNICO: NCT01540019

BioSeek: nct01540019

Palabras clave

Abstracto

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.

Descripción

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.

fechas

Verificado por última vez:	12/31/2011
Primero enviado:	01/28/2012
Inscripción estimada enviada:	02/21/2012
Publicado por primera vez:	02/27/2012
Última actualización enviada:	02/21/2012
Última actualización publicada:	02/27/2012
Fecha de inicio real del estudio:	03/31/2011
Fecha estimada de finalización primaria:	06/30/2013
Fecha estimada de finalización del estudio:	06/30/2013

Condición o enfermedad

Cancer-related Problem/Condition

Anorexia

Loss of Weight

Intervención / tratamiento

Drug: Paullinea cupana

Fase

Fase 1/Fase 2

Grupos de brazos

Brazo	Intervención / tratamiento
Experimental: Paullinea cupana 50mg of Paullinia cupana as capsule, twice daily	Drug: Paullinea cupana 50mg of Paullinia cupana as capsule, twice daily

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Acepta voluntarios saludables	si
Criterios	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

Salir

Medidas de resultado primarias

1. weight [eight weeks]

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

Medidas de resultado secundarias

1. quality of life [eight weeks]

Weekly patients will answer questionaries about quality of life like FACT-G

Paullinia Cupana for Anorexia in Oncologic Patients

Palabras clave

anorexia

cáncer

cansancio

cefalea

inflamación

caquexia

mialgia

creatinina

paullinia

pérdida de peso

quimioterapia