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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faculdade de Medicina do ABC
• Treatments: Carbamazepine

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.