Paullinia Cupana for Anorexia in Oncologic Patients
Palabras clave
Abstracto
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
Intervención / tratamiento
Drug: Paullinea cupana
Fase
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]
Medidas de resultado secundarias
1. quality of life [eight weeks]