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

Primary Purpose

Emesis

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
olanzapine
metoclopramide
Sponsored by
Karin Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Emesis focused on measuring break-through, emesis, break through emesis after prophylaxis with dexamethasone, 5-HT 3RA and aprepitant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

olanzapine

metoclopramide

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

safety
according to NCI-CTC-AE version4.0
Quality of life
using EORTC-QLQ-C30
change in urinary excretion of 5 hydroxy indole acetic acid
measurement in 24 hours urine samples

Full Information

First Posted
June 21, 2010
Last Updated
May 10, 2016
Sponsor
Karin Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT01148264
Brief Title
Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis
Acronym
COMFORT
Official Title
Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
poor enrolment
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karin Jordan

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emesis
Keywords
break-through, emesis, break through emesis after prophylaxis with dexamethasone, 5-HT 3RA and aprepitant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
olanzapine
Arm Type
Experimental
Arm Title
metoclopramide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
1x10mg per day for three days
Intervention Type
Drug
Intervention Name(s)
metoclopramide
Other Intervention Name(s)
Paspertin
Intervention Description
3x10mg per day for three days
Primary Outcome Measure Information:
Title
Clinical benefit rate
Description
no vomitus, no further rescue medication, nausea < 25mm on the visual analog scale (VAS) or reduction on the VAS of >50%
Time Frame
three days
Secondary Outcome Measure Information:
Title
safety
Description
according to NCI-CTC-AE version4.0
Time Frame
five days
Title
Quality of life
Description
using EORTC-QLQ-C30
Time Frame
5 days
Title
change in urinary excretion of 5 hydroxy indole acetic acid
Description
measurement in 24 hours urine samples
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Jordan, MD
Organizational Affiliation
Martin-Luther-University Halle-Wittenberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06097
Country
Germany

12. IPD Sharing Statement

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Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

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