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

NCT01581918 | Unknown Phase 2 DMC

• 1 other identifier: thaiana123
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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.

  120hours

Secondary Outcomes (1)

• Safety of Carbamazepine

  120hours

Interventions

Carbamazepine DRUG

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• previuos chemotherapy
• low emetogenic antiemetic potential
• disagree and don't sign in the consent form.

Sponsors & Collaborators

• Faculdade de Medicina do ABC: lead

Study Sites (1)

ABC Medical School

Santo André, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Vomiting

Interventions

Carbamazepine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

THAIANA SANTANA, SUPERIOR

CONTACT

9891-6585; thaianaa@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHASE II STUDY TO EVALUATE EFFICACY AND SAFETY OF CARBAMAZEPINE FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: December 1, 2011
• Primary Completion: March 1, 2012
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

BR (1)