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Guarana (Paullinia Cupana) for Anorexia Related to Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer-related Problem/Condition, Anorexia, Loss of Weight

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Trial Information

Guarana (Paullinia Cupana) for Anorexia Related to Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

weight

Outcome Description:

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

Outcome Time Frame:

eight weeks

Safety Issue:

No

Principal Investigator

Claudia Latorre

Investigator Role:

Study Chair

Investigator Affiliation:

Faculdade de Medicina do ABC

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

FaculdadeMABC

NCT ID:

NCT01540019

Start Date:

April 2011

Completion Date:

July 2013

Related Keywords:

  • Cancer-Related Problem/Condition
  • Anorexia
  • Loss of Weight
  • anorexia
  • Paullinia cupana
  • loss of weight
  • Anorexia
  • Weight Loss

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