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

Study Overview
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Brief Summary
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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
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: morphine gel
* Drug: placebo gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral morphine gel<br>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<br>* 1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose<br>* Other names: Morphine hydrochloride,;|
| Placebo Comparator: placebo gel<br>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<br>* 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<br>* Other names: sterile Placebo gel;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, mucositis, systemic opioids, morphine