Evaluation of Oral Morphine Gel in Oral Mucositis Induced by Chemotherapy in Children and Young Adults (MorphinOgel)

Chemotherapy kills tumor cells but can also damage healthy cells and cause significant digestive disorders such as ulcers of the mouth, called mucositis. Mucositis are transient but their intensity may require special measures. Mucositis are painful and morphine gel or intravenous morphine is used to relieve pain.

However, the pain of oral mucositis induced by chemotherapy is not completely relieved by morphine administered intravenously.

As part of the study, the investigators want to evaluate an oral gel containing a small amount of morphine so that it acts directly on the mucositis. The investigators believe that the direct action of morphine on mucositis may be more effective on pain.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Drug: morphine gel; Drug: placebo gel

Detailed Description

The objective of the study is to compare the analgesic efficacy of topical morphine gel versus placebo gel in the pediatric oncohaematology oral mucositis induced by chemotherapy in children treated with systemic opioids.

To confirm these results, we propose to conduct a randomized double-blinded study designed to compare the analgesic efficacy of morphine oral topical gel versus placebo gel in children over 5 years with mucositis induced by chemotherapy and treated with systemic opioids. This analgesic effect should reduce persistent pain to maintain oral feeding and thus delay the implementation of parenteral nutrition, and hence reduce the dose of systemic morphine and also reduce the adverse effects of opioids

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Patrick Lutz, MD; Phone Number: 0388128091; Email: patrick.lutz@chru-strasbourg.fr

Study Locations

• France
  • Alsace
    • Strasbourg, Alsace, France, 67098
      • Service d'oncohématologie pédiatrique, Hôpital de Hautepierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children older than 5 years or adults over 18 and up to 25 years with a chemotherapy
• greater than or equal to grade 2 mucositis that has lasted for 24 hours and treated with systemic opioid

Exclusion Criteria:

• Patients in emergency ward -Patients having difficulties in understanding the study -
• Patients who have already been treated with oral morphine gel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral morphine gel; 1 mg / ml of Morphine hydrochloride, presented in a 5 mL sterile syringe (single dose). Gel will be applied 8 times per day and for the duration of the mucositis (between 8 to 21 days).	Drug: morphine gel; 1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose; Other Names: Morphine hydrochloride,
Placebo Comparator: placebo gel; 1 mg / ml of Placebo gel that is presented in a 5 mL sterile syringe (single dose). Gel will be applied 8 times per day and for the duration of the mucositis (between 8 to 21 days).	Drug: placebo gel; Sterile placebo gel with raspberry aroma, 30% glucose presented in 5 mL syringe (single dose) of the same appearance and the same packaging as morphine gel to maintain the blind; Other Names: sterile Placebo gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in pain of mucositis before and after meal	Pain is assessed before gel application and 30 minutes after application (i e 8 times per day and for the duration of the mucositis between 8 to 21 days). The gel is administered 4 times daily 30 minutes before each meal. Response to treatment is defined as a greater than or equal to 30% decrease in pain level between before and after application of the gel.	Daily assessment through out the mucositis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis	Evaluation of the local tolerance ( taste, burns) with a questionnaire	daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis	Assessment of the quantity of morphine in mg/ day (reported in mg morphine), the nature and amount of all systemic analgesics	daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis	Daily grading of mucositis by the doctor	daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis	Daily evaluation of other topical treatments administered (mouthwashes: time frames when administered, doses, nature)	daily, 8-21 days throughout the mucositis

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: June 14, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Estimate): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: chemotherapy; morphine; mucositis; systemic opioids
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 5092