Chemotherapy-induced Nausea and VomitingPhase 2NCT01581918
Efficacy and Safety Evaluation of Carbamazepine for Prevention of Chemotherapy-induced Nausea and Vomiting
A Phase 2 study testing Carbamazepine in people with Chemotherapy-induced Nausea and Vomiting, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
Nausea and vomiting are common problems for cancer patients. Half of them will experience these symptoms during the course of their disease, either because of the cancer itself or because of their treatment1. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Carbamazepine
- Type of treatment
- Pill or oral medicine
- How many people
- 43 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Mar 2012
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years old
- starting moderate or highly emetogenic chemotherapy defined as containing cisplatin,doxorrubicin or epirrubicin in higher doses than 60mg/m2, 50mg/m2 e 50mg/m2 respectively
- they must sign in the informed consent form.
Who cannot join
- previuos chemotherapy
- low emetogenic antiemetic potential
- disagree and don't sign in the consent form.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
ABC Medical School
Santo André, São Paulo
Thaiana Santana, (11)98916585, thaianaa@yahoo.com.br
About this study
Official title: PHASE II STUDY TO EVALUATE EFFICACY AND SAFETY OF CARBAMAZEPINE FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.
Nausea and vomiting are common problems for cancer patients. Half of them will experience these symptoms during the course of their disease, either because of the cancer itself or because of their treatment1. They are ranked by patients as two of the worst adverse effects of cancer chemotherapy and cause a negative impact on patient's functional, emotional, social and nutritional status and quality of life2,3.
Nowadays, a wide variety of antiemetic agents are available for the prevention and treatment of CINV. In this scenario, three classes play a critical role: Selective 5-HT3-receptor antagonists - approved for clinical practice in early 1990s, revolutionized the management of CINV representing the most effective agents in the treatment of acute emesis -, Corticosteroids - with unknown mechanism of action, effective when administered as single agents in patients receiving chemotherapy of low emetic potential but are most beneficial when used in combination with other antiemetic agents, potentiating their anti-emetic efficacy in both acute and delayed symptoms - and neurokinin 1 receptor antagonist - also effective against both acute and delayed emesis, but restricted utility in daily clinical practice because of its high cost.
Read the detailed description
Meanwhile there are a lot of studies with these three classes of drugs, some efforts are being done to reach higher control rates of CINV with different drugs. In this scenario, in a randomized phase II placebo-controlled trial Cruz et. al. demonstrated that Gabapentin raises chemotherapy-induced nausea and vomiting control when associated with Dexametason and Ondasetron, suggesting that it could be a cost-effective alternative to neurokinin 1 receptor antagonists9, although, as we know, there aren't comparative studies with gabapentin and aprepitant. Guttuso et al demonstrated in an open clinical study the antiemetic effect of gabapentin in chemotherapy-induced acute (within 24hs) and delayed onset (days 2-5) nausea and vomiting in breast cancer patients with refractory emesis10.
Tan e cols showed higher complete and delayed nausea and vomiting control rates for olanzapine vs. aprepitant, in association with palonosetron and dexametason in highly and moderately emetogenic potential chemotherapy11. Navari e cols haven't found similar results although this comparison may not be done, since maintenance anti-emetic treatment was different between these studies12.
In a case report, Strohscheer I. \& Borasio GD showed complete control of refractory nausea and vomiting in one patient with meningeal carcinomatosis treated with Carbamazepine13.
Carbamazepine is an available anticonvulsant largely used in Brazil. The aim of this study is to evaluate the role of Carbamazepine for the prevention of nausea and vomiting induced by moderate and highly emetogenic chemotherapy.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Carbamazepine
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
Patients will receive Carbamazepine in first chemotherapy cycle as planned: - One tablet (200mg) at night on third day before chemotherapy; - One tablet (200mg) every 12 hours on second day before chemotherapy; - One tablet (200mg) every 8 hours from the day before until fifth day after chemotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Carbamazepine
To evaluate complete protection (CP) of chemotherapy induced nausea and vomiting, defined as the percentage of patients without nausea or vomiting and the absence of use of rescue medication.
Measured: 120hours
Secondary outcomes (1)
Safety of Carbamazepine
Number of Adverse Events and possible impact in quality of life related to carbamazepine treatment.
Measured: 120hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT01581918
- Sponsor's protocol ID
- thaiana123
- Status last verified
- Apr 2012
- First submitted
- 19 Apr 2012
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II STUDY TO EVALUATE EFFICACY AND SAFETY OF CARBAMAZEPINE FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.
- ClinicalTrials.gov ID
- NCT01581918
- Acronym / sponsor ID
- thaiana123
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- First posted
- 20 Apr 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.
Nausea and vomiting are common problems for cancer patients. Half of them will experience these symptoms during the course of their disease, either because of the cancer itself or because of their treatment1. They are ranked by patients as two of the worst adverse effects of cancer chemotherapy and cause a negative impact on patient's functional, emotional, social and nutritional status and quality of life2,3.
Nowadays, a wide variety of antiemetic agents are available for the prevention and treatment of CINV. In this scenario, three classes play a critical role: Selective 5-HT3-receptor antagonists - approved for clinical practice in early 1990s, revolutionized the management of CINV representing the most effective agents in the treatment of acute emesis -, Corticosteroids - with unknown mechanism of action, effective when administered as single agents in patients receiving chemotherapy of low emetic potential but are most beneficial when used in combination with other antiemetic agents, potentiating their anti-emetic efficacy in both acute and delayed symptoms - and neurokinin 1 receptor antagonist - also effective against both acute and delayed emesis, but restricted utility in daily clinical practice because of its high cost.
Detailed description
Meanwhile there are a lot of studies with these three classes of drugs, some efforts are being done to reach higher control rates of CINV with different drugs. In this scenario, in a randomized phase II placebo-controlled trial Cruz et. al. demonstrated that Gabapentin raises chemotherapy-induced nausea and vomiting control when associated with Dexametason and Ondasetron, suggesting that it could be a cost-effective alternative to neurokinin 1 receptor antagonists9, although, as we know, there aren't comparative studies with gabapentin and aprepitant. Guttuso et al demonstrated in an open clinical study the antiemetic effect of gabapentin in chemotherapy-induced acute (within 24hs) and delayed onset (days 2-5) nausea and vomiting in breast cancer patients with refractory emesis10.
Tan e cols showed higher complete and delayed nausea and vomiting control rates for olanzapine vs. aprepitant, in association with palonosetron and dexametason in highly and moderately emetogenic potential chemotherapy11. Navari e cols haven't found similar results although this comparison may not be done, since maintenance anti-emetic treatment was different between these studies12.
In a case report, Strohscheer I. \& Borasio GD showed complete control of refractory nausea and vomiting in one patient with meningeal carcinomatosis treated with Carbamazepine13.
Carbamazepine is an available anticonvulsant largely used in Brazil. The aim of this study is to evaluate the role of Carbamazepine for the prevention of nausea and vomiting induced by moderate and highly emetogenic chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older than 18 years old
- starting moderate or highly emetogenic chemotherapy defined as containing cisplatin,doxorrubicin or epirrubicin in higher doses than 60mg/m2, 50mg/m2 e 50mg/m2 respectively
- they must sign in the informed consent form.
Key exclusion criteria (3 listed)
- previuos chemotherapy
- low emetogenic antiemetic potential
- disagree and don't sign in the consent form.
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 |
|---|---|---|
| CarbamazepinePatients will receive Carbamazepine in first chemotherapy cycle as planned: - One tablet (200mg) at night on third day before chemotherapy; - One tablet (200mg) every 12 hours on second day before chemotherapy; - One tablet (200mg) every 8 hours from the day before until fifth day after chemotherapy. | Drug | – |
Primary outcome
Efficacy of Carbamazepine
Time frame: 120hours
To evaluate complete protection (CP) of chemotherapy induced nausea and vomiting, defined as the percentage of patients without nausea or vomiting and the absence of use of rescue medication.
1 secondary outcome
Safety of Carbamazepine
Time frame: 120hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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.
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 Carbamazepine in people with Chemotherapy-induced Nausea and Vomiting, 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 3 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 24 Apr 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 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 THAIANA SANTANA, SUPERIOR (9891-6585, thaianaa@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Carbamazepine (time frame: 120hours). 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 24 Apr 2012.