Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis (COMFORT)

Karin Jordan

Status and phase: Terminated; Phase 2

Conditions: Emesis

Treatments: Drug: metoclopramide; Drug: olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01148264

KKSH 079

2010-018665-30 (EudraCT Number)

Details and patient eligibility

About

This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea>25mm on VAS
• signed IC

Exclusion criteria

• psychiatric disorders
• drug abuse
• pregnancy
• high dose chemotherapy
• treatment with other antiemetic drugs

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups

olanzapine

Experimental group

Treatment:

Drug: olanzapine

metoclopramide

Active Comparator group

Treatment:

Drug: metoclopramide