Paullinia Cupana for Anorexia in Oncologic Patients

Anorexia Clinical Trial

Official title:

Guarana (Paullinia Cupana) for Anorexia Related to Cancer

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01540019
• Other study ID #: FaculdadeMABC
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: January 29, 2012
• Last updated: February 22, 2012
• Start date: April 2011
• Est. completion date: July 2013

Study information

• Verified date: January 2012
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 35
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Cancer-related Problem/Condition
• Loss of Weight
• Weight Loss

Intervention

Drug:
• Paullinia cupana
50mg of Paullinia cupana as capsule, twice daily

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	Patients will considered to respond to guaraná if the gain 5% or more of his inicial weight during the treatment period	eight weeks
Secondary	quality of life	Weekly patients will answer questionaries about quality of life like FACT-G	eight weeks