NCT01540019

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 28, 2012

Status Verified

January 1, 2012

Enrollment Period

2.3 years

First QC Date

January 29, 2012

Last Update Submit

February 22, 2012

Conditions

Cancer-related Problem/ConditionAnorexiaLoss of Weight

Keywords

anorexiaPaullinia cupanaloss of weight

Outcome Measures

Primary Outcomes (1)

  • weight

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

    eight weeks

Secondary Outcomes (1)

  • quality of life

    eight weeks

Study Arms (1)

Paullinea cupana

EXPERIMENTAL

50mg of Paullinia cupana as capsule, twice daily

Drug: Paullinia cupana

Interventions

Paullinia cupanaDRUG

50mg of Paullinia cupana as capsule, twice daily

Paullinea cupana

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults (18 years old and older)
  • palliative care or oncologic treatment
  • loss of weight
  • anorexia

You may not qualify if:

  • gastrointestinal obstruction
  • blood pressure not controlled
  • diabetes not treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

RECRUITING

MeSH Terms

Conditions

AnorexiaWeight Loss

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBody Weight

Study Officials

  • Claudia Latorre

    Faculdade de Medicina do ABC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC

Study Record Dates

First Submitted

January 29, 2012

First Posted

February 28, 2012

Study Start

April 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

February 28, 2012

Record last verified: 2012-01

Locations

BR(1)