Solid TumorsPhase 2cat´sclawNCT02045719
Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors
A Phase 2 study testing uncaria tomentosa (cat´s claw) in people with Solid Tumors, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. Patients and methods: This prospective phase II study will assess the effects of a 100-mg dose of a dry extract of U. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- uncaria tomentosa (cat´s claw)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2013to Sep 2014
- Phase
- Phase 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
- individuals with advanced solid tumors, with no further therapeutic options and with at least 2 moths life expectancy
- individuals 18 years of age and older
- creatinine levels up to twice the upper limit of normal (ULN)
- alanine (ALT) and aspartate (ASP) transaminase levels up to twice the ULN and direct bilirubin (DB) levels up to 1.5 times the ULN
- in cases with pre-existing liver disease, the ALT, ASP and DB levels could be up to 2.5 times the ULN
Who cannot join
- pregnant and breastfeeding women
- individuals using chemotherapy or other tumor-targeting antineoplastic treatments, except for antalgic radiotherapy
- severe kidney or liver failure
- known hypersensitiveness to the components of the medication used
- past history of emotional disorders that could interfere with the data collection.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Estudos e Pesquisa em Hematologia e Oncologia
Santo André, São Paulo, 09060-650
Larissa de Paula, 55992951626, lariclpaula@hotmail.com
About this study
Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. Patients and methods: This prospective phase II study will assess the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on individuals with advanced solid tumors, with no further therapeutic options and with at least 2 months life expectancy. In addition, several biochemical and inflammatory parameters will be analyzed.
- Conditions
- Solid Tumors
- Being tested
- uncaria tomentosa (cat´s claw)
- Keywords
- cat´s claw, uncaria tomentosa, quality of life, no further therapeutic options
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uncaria tomentosa (cat´s claw)Drug
Also called 100 mg dose of a dry extract of U. tomentosa three times per day
| Study group | Role | What they receive |
|---|---|---|
| cat's claw | Experimental | 100 mg dose of a dry extract of U. tomentosa three times per day Receives: Drug: uncaria tomentosa (cat´s claw) |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of benefits on quality of life after treatment during two months
Assess the efficacy and safety of a dry extract of U. tomentosa on individuals who had solid tumors with no further therapeutic options
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045719
- Sponsor's protocol ID
- ABC2013
- Acronym
- cat´sclaw
- Status last verified
- Jan 2014
- First submitted
- 23 Jan 2014
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02045719
- Acronym / sponsor ID
- cat´sclaw / ABC2013
- Conditions
- Solid Tumors
- Keywords
- cat´s claw, uncaria tomentosa, quality of life, no further therapeutic options
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 27 Jan 2014 (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.
Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. Patients and methods: This prospective phase II study will assess the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on individuals with advanced solid tumors, with no further therapeutic options and with at least 2 months life expectancy. In addition, several biochemical and inflammatory parameters will be analyzed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cat's claw | Experimental | Drug: uncaria tomentosa (cat´s claw)100 mg dose of a dry extract of U. tomentosa three times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- individuals with advanced solid tumors, with no further therapeutic options and with at least 2 moths life expectancy
- individuals 18 years of age and older
- creatinine levels up to twice the upper limit of normal (ULN)
- alanine (ALT) and aspartate (ASP) transaminase levels up to twice the ULN and direct bilirubin (DB) levels up to 1.5 times the ULN
- in cases with pre-existing liver disease, the ALT, ASP and DB levels could be up to 2.5 times the ULN
Key exclusion criteria (5 listed)
- pregnant and breastfeeding women
- individuals using chemotherapy or other tumor-targeting antineoplastic treatments, except for antalgic radiotherapy
- severe kidney or liver failure
- known hypersensitiveness to the components of the medication used
- past history of emotional disorders that could interfere with the data collection.
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 |
|---|---|---|
| uncaria tomentosa (cat´s claw)Also: 100 mg dose of a dry extract of U. tomentosa three times per day | Drug | cat's claw |
Primary outcome
assessment of benefits on quality of life after treatment during two months
Time frame: two months
Assess the efficacy and safety of a dry extract of U. tomentosa on individuals who had solid tumors with no further therapeutic options
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing uncaria tomentosa (cat´s claw) in people with Solid Tumors, 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 5 inclusion and 5 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 27 Jan 2014. 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 phase mean?
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?
Contact Larissa de Paula (5511992951626, lariclpaula@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of benefits on quality of life after treatment during two months (time frame: two months). 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 27 Jan 2014.