COMFORT: Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

• Sponsor: Karin Jordan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01148264
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Emesis	Drug: olanzapine; Drug: metoclopramide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: olanzapine	Drug: olanzapine; 1x10mg per day for three days; Other Names: Zyprexa
Active Comparator: metoclopramide	Drug: metoclopramide; 3x10mg per day for three days; Other Names: Paspertin

Outcome Measures

Primary Outcome Measures

1. Clinical benefit rate [three days]

   no vomitus, no further rescue medication, nausea < 25mm on the visual analog scale (VAS) or reduction on the VAS of >50%

Secondary Outcome Measures

1. safety [five days]

   according to NCI-CTC-AE version4.0

2. Quality of life [5 days]

   using EORTC-QLQ-C30

3. change in urinary excretion of 5 hydroxy indole acetic acid [5 days]

   measurement in 24 hours urine samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40	Halle (Saale)	Sachsen-Anhalt	Germany	06097

Sponsors and Collaborators

• Karin Jordan

Investigators

• Principal Investigator: Karin Jordan, MD, Martin-Luther-University Halle-Wittenberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karin Jordan, MD, Martin-Luther-Universität Halle-Wittenberg
• ClinicalTrials.gov Identifier: NCT01148264
• Other Study ID Numbers: KKSH 079; 2010-018665-30
• First Posted: Jun 22, 2010
• Last Update Posted: May 11, 2016
• Last Verified: May 1, 2016

• Keywords provided by Karin Jordan, MD, Martin-Luther-Universität Halle-Wittenberg: break-through; emesis; break through emesis after prophylaxis with dexamethasone, 5-HT 3RA and aprepitant
• Additional relevant MeSH terms: Vomiting; Olanzapine; Metoclopramide

Study Results

No Results Posted as of May 11, 2016