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Paullinia Cupana for Anorexia in Oncologic Patients

This study is currently recruiting participants.
Verified January 2012 by Faculdade de Medicina do ABC
Sponsor:
Information provided by (Responsible Party):
Felipe Melo Cruz, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT01540019
First received: January 29, 2012
Last updated: February 22, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer-related Problem/Condition
Anorexia
Loss of Weight
 Drug: Paullinia cupana
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guarana (Paullinia Cupana) for Anorexia Related to Cancer

Resource links provided by NLM:

Drug Information available for: Paullinia
U.S. FDA Resources

Further study details as provided by Faculdade de Medicina do ABC:

Primary Outcome Measures:
  • weight [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
    Patients will considered to respond to guaraná if the gain 5% or more of his inicial weight during the treatment period


Secondary Outcome Measures:
  • quality of life [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
    Weekly patients will answer questionaries about quality of life like FACT-G


Estimated Enrollment: 35
Study Start Date: April 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paullinea cupana
50mg of Paullinia cupana as capsule, twice daily
 Drug: Paullinia cupana
50mg of Paullinia cupana as capsule, twice daily

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540019

Locations
Brazil
Faculdade de Medicina do ABC Recruiting
Santo André, São Paulo, Brazil, 09060-650
Contact: Claudia Latorre     55117717-3241     claudiaglatorre@gmail.com    
Sponsors and Collaborators
Faculdade de Medicina do ABC
Investigators
Study Chair: Claudia Latorre Faculdade de Medicina do ABC
  More Information

No publications provided

Responsible Party: Felipe Melo Cruz, MsC, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT01540019     History of Changes
Other Study ID Numbers: FaculdadeMABC
Study First Received: January 29, 2012
Last Updated: February 22, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade de Medicina do ABC:
anorexia
Paullinia cupana
loss of weight

Additional relevant MeSH terms:
Anorexia
Weight Loss
Signs and Symptoms, Digestive
 Signs and Symptoms
Body Weight Changes
Body Weight

ClinicalTrials.gov processed this record on May 19, 2013