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Paullinia Cupana for Anorexia in Oncologic Patients

Guarana (Paullinia Cupana) for Anorexia Related to Cancer

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01540019
Enrollment
35
Registered
2012-02-28
Start date
2011-04-30
Completion date
2013-07-31
Last updated
2012-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

anorexia, Paullinia cupana, loss of weight

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.

Interventions

DRUGPaullinia cupana

50mg of Paullinia cupana as capsule, twice daily

Sponsors

Faculdade de Medicina do ABC
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
weighteight weeksPatients will considered to respond to guaraná if the gain 5% or more of his inicial weight during the treatment period

Secondary

MeasureTime frameDescription
quality of lifeeight weeksWeekly patients will answer questionaries about quality of life like FACT-G

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026