Efficacy and Safety Evaluation of Carbamazepine for Prevention of Chemotherapy-induced Nausea and Vomiting

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Faculdade de Medicina do ABC.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Felipe Melo Cruz, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT01581918
First received: April 19, 2012
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Chemotherapy-induced Nausea and Vomiting
Drug: Carbamazepine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PHASE II STUDY TO EVALUATE EFFICACY AND SAFETY OF CARBAMAZEPINE FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.

Resource links provided by NLM:


Further study details as provided by Faculdade de Medicina do ABC:

Primary Outcome Measures:
  • Efficacy of Carbamazepine [ Time Frame: 120hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety of Carbamazepine [ Time Frame: 120hours ] [ Designated as safety issue: Yes ]
    Number of Adverse Events and possible impact in quality of life related to carbamazepine treatment.


Estimated Enrollment: 43
Study Start Date: December 2011
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Carbamazepine
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • previuos chemotherapy
  • low emetogenic antiemetic potential
  • disagree and don't sign in the consent form.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581918

Contacts
Contact: THAIANA SANTANA, SUPERIOR 9891-6585 thaianaa@yahoo.com.br

Locations
Brazil
ABC Medical School Recruiting
Santo André, São Paulo, Brazil
Contact: Thaiana Santana    (11)98916585    thaianaa@yahoo.com.br   
Sponsors and Collaborators
Faculdade de Medicina do ABC
  More Information

No publications provided

Responsible Party: Felipe Melo Cruz, PHASE II STUDY TO EVALUATE EFFICACY AND SAFETY OF CARBAMAZEPINE FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING., Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT01581918     History of Changes
Other Study ID Numbers: thaiana123
Study First Received: April 19, 2012
Last Updated: April 23, 2012
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Carbamazepine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 22, 2014