Paullinia Cupana for Anorexia in Oncologic Patients

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Status

Sponzori

Faculdade de Medicina do ABC

KLINIČKIM ISPITIVANJIMA: NCT01540019

BioSeek: nct01540019

Ključne riječi

Sažetak

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.

Opis

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.

Datumi

Posljednja provjera:	12/31/2011
Prvo podneseno:	01/28/2012
Predviđena prijava predata:	02/21/2012
Prvo objavljeno:	02/27/2012
Zadnje ažuriranje poslato:	02/21/2012
Posljednje ažuriranje objavljeno:	02/27/2012
Stvarni datum početka studija:	03/31/2011
Procijenjeni datum primarnog završetka:	06/30/2013
Predviđeni datum završetka studije:	06/30/2013

Stanje ili bolest

Cancer-related Problem/Condition

Anorexia

Loss of Weight

Intervencija / liječenje

Drug: Paullinea cupana

Faza

Faza 1/Faza 2

Grupe ruku

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

Kriteriji prihvatljivosti

Uzrast podoban za studiranje	18 Years To 18 Years
Polovi podobni za studiranje	All
Prihvaća zdrave volontere	Da
Kriterijumi	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

Ishod

Primarne mjere ishoda

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

Sekundarne mjere ishoda

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

Ključne riječi

anoreksija

rak

umor

glavobolja

upala

cachexia

myalgia

creatinine

paullinia

gubitak težine

hemoterapija