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Paullinia Cupana for Anorexia in Oncologic Patients

Primary Purpose

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

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Paullinia cupana
Sponsored by
Faculdade de Medicina do ABC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Problem/Condition focused on measuring anorexia, Paullinia cupana, loss of weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculdade de Medicina do ABCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paullinea cupana

Arm Description

50mg of Paullinia cupana as capsule, twice daily

Outcomes

Primary Outcome Measures

weight
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
Weekly patients will answer questionaries about quality of life like FACT-G

Full Information

First Posted
January 29, 2012
Last Updated
February 22, 2012
Sponsor
Faculdade de Medicina do ABC
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1. Study Identification

Unique Protocol Identification Number
NCT01540019
Brief Title
Paullinia Cupana for Anorexia in Oncologic Patients
Official Title
Guarana (Paullinia Cupana) for Anorexia Related to Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Medicina do ABC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Problem/Condition, Anorexia, Loss of Weight
Keywords
anorexia, Paullinia cupana, loss of weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paullinea cupana
Arm Type
Experimental
Arm Description
50mg of Paullinia cupana as capsule, twice daily
Intervention Type
Drug
Intervention Name(s)
Paullinia cupana
Intervention Description
50mg of Paullinia cupana as capsule, twice daily
Primary Outcome Measure Information:
Title
weight
Description
Patients will considered to respond to guaraná if the gain 5% or more of his inicial weight during the treatment period
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
quality of life
Description
Weekly patients will answer questionaries about quality of life like FACT-G
Time Frame
eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Latorre
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Study Chair
Facility Information:
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Latorre
Phone
55117717-3241
Email
claudiaglatorre@gmail.com

12. IPD Sharing Statement

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Paullinia Cupana for Anorexia in Oncologic Patients

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