Clinical trial NCT02173756: Evaluation of Oral Morphine Gel in Oral Mucositis Induced by Chemotherapy in Children and Young Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer
Keywords: chemotherapy
mucositis
systemic opioids
morphine
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: change in pain of mucositis before and after meal
timeFrame: Daily assessment through out the mucositis
Secondary outcomes:
measure: Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
timeFrame: daily, 8-21 days throughout the mucositis
measure: Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
timeFrame: daily, 8-21 days throughout the mucositis
measure: Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
timeFrame: daily, 8-21 days throughout the mucositis
measure: Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
timeFrame: daily, 8-21 days throughout the mucositis
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'oncohématologie pédiatrique, Hôpital de Hautepierre
state: Alsace
Study officials:
References: