Cancer-related Problem/ConditionPhase 1/2NCT01540019
Paullinia Cupana for Anorexia in Oncologic Patients
A Phase 1/2 study testing Paullinia cupana in people with Cancer-related Problem/Condition and Anorexia, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Problem/Condition, Anorexia, Loss of Weight
- What is being tested?
- Paullinia cupana
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Jul 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (18 years old and older)
- palliative care or oncologic treatment
- loss of weight
- anorexia
Who cannot join
- gastrointestinal obstruction
- blood pressure not controlled
- diabetes not treated
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
Claudia Latorre, 55117717-3241, claudiaglatorre@gmail.com
About this study
Official title: Guarana (Paullinia Cupana) for Anorexia Related to Cancer
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.
Read the 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.
- Conditions
- Cancer-related Problem/Condition, Anorexia, Loss of Weight
- Being tested
- Paullinia cupana
- Keywords
- anorexia, Paullinia cupana, loss of weight
- Medical subject headings
- Anorexia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paullinia cupanaDrug
50mg of Paullinia cupana as capsule, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Paullinea cupana | Experimental | 50mg of Paullinia cupana as capsule, twice daily Receives: Drug: Paullinia cupana |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Patients will considered to respond to guaraná if the gain 5% or more of his inicial weight during the treatment period
Measured: eight weeks
Secondary outcomes (1)
quality of life
Weekly patients will answer questionaries about quality of life like FACT-G
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startApr 2011
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Melo Cruz, Faculdade de Medicina do ABC
- Investigators
- Claudia Latorre, Study chair, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540019
- Sponsor's protocol ID
- FaculdadeMABC
- Status last verified
- Jan 2012
- First submitted
- 29 Jan 2012
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guarana (Paullinia Cupana) for Anorexia Related to Cancer
- ClinicalTrials.gov ID
- NCT01540019
- Acronym / sponsor ID
- FaculdadeMABC
- Conditions
- Cancer-related Problem/Condition, Anorexia, Loss of Weight
- Keywords
- anorexia, Paullinia cupana, loss of weight
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paullinea cupana | Experimental | Drug: Paullinia cupana50mg of Paullinia cupana as capsule, twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults (18 years old and older)
- palliative care or oncologic treatment
- loss of weight
- anorexia
Key exclusion criteria (3 listed)
- gastrointestinal obstruction
- blood pressure not controlled
- diabetes not treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paullinia cupana50mg of Paullinia cupana as capsule, twice daily | Drug | Paullinea cupana |
Primary outcome
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
1 secondary outcome
quality of life
Time frame: eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Latorre study chair
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paullinia cupana in people with Cancer-related Problem/Condition and Anorexia, run by Faculdade de Medicina do ABC at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.