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

Phase 3

• Conditions: Cancer
• Interventions: Drug: morphine gel; Drug: placebo gel

• Registration Number: NCT02173756
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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.

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 Timeline

• Status Verified: 2014-06
• Study Start: 2014-06
• Study First Submitted: 2014-06-14
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-25
• Last Update Posted: 2014-06-25
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral morphine gel	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).
placebo gel	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).

Primary Outcome Measures

Name	Time	Method
change in pain of mucositis before and after meal	Daily assessment through out the mucositis	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis	daily, 8-21 days throughout the mucositis	Daily evaluation of other topical treatments administered (mouthwashes: time frames when administered, doses, nature)

Trial Locations

Locations (1)

Service d'oncohématologie pédiatrique, Hôpital de Hautepierre; 🇫🇷 Strasbourg, Alsace, France