- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01540019
Paullinia Cupana for Anorexia in Oncologic Patients
Guarana (Paullinia Cupana) for Anorexia Related to Cancer
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
São Paulo
-
Santo André, São Paulo, Brazil, 09060-650
- Recruiting
- Faculdade de Medicina do ABC
-
Contact:
- Claudia Latorre
- Phone Number: 55117717-3241
- Email: claudiaglatorre@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paullinea cupana
50mg of Paullinia cupana as capsule, twice daily
|
50mg of Paullinia cupana as capsule, twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight
Time Frame: eight weeks
|
Patients will considered to respond to guaraná if the gain 5% or more of his inicial weight during the treatment period
|
eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life
Time Frame: eight weeks
|
Weekly patients will answer questionaries about quality of life like FACT-G
|
eight weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Claudia Latorre, Faculdade de Medicina do ABC
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FaculdadeMABC
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