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

Condition(s) targeted: Cancer

Intervention: morphine gel (Drug); placebo gel (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: University Hospital, Strasbourg, France

Overall contact:
Patrick Lutz, MD, Phone: 0388128091, Email: patrick.lutz@chru-strasbourg.fr

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: change in pain of mucositis before and after meal

Secondary outcome:

Evaluation of the local tolerance and other topical treatment taken throughout the mucositis

Evaluation of the local tolerance and other topical treatment taken throughout the mucositis

Evaluation of the local tolerance and other topical treatment taken throughout the mucositis

Evaluation of the local tolerance and other topical treatment taken throughout the mucositis

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

Minimum age: 5 Years. Maximum age: 25 Years. Gender(s): Both.

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

Patrick Lutz, MD, Phone: 0388128091, Email: patrick.lutz@chru-strasbourg.fr

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

Starting date: June 2014
Last updated: June 20, 2014