Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer

Phase 2

Completed

• Conditions: Stomatitis
• Interventions: Drug: Magnesium aluminum hydroxide; Drug: 2% morphine solution; Drug: 2% viscous lidocaine; Drug: Diphenhydramine

• Registration Number: NCT01837446
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

Oral mucositis is a debilitating side effects of cancer treatment for which there is not much successful treatments at yet. The investigators are going to evaluate the effectiveness of topical morphine compared with a routine mouthwash in managing cancer treatment-induced mucositis. The investigators hypothesize that topical morphine is more effective and more satisfied by patients than the magic mouthwash in reducing severity of cancer treatment-induced oral mucositis.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Study First Submitted: 2013-02-26
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-22
• Last Update Submitted: 2013-04-22
• Study First Posted: 2013-04-23
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Head and neck cancer patients
• Severe oral mucositis; grade III or IV of the World Health Organization (WHO) rating of global mucositis
• Willingness to participate

Exclusion Criteria

• History of severe renal or hepatic insufficiency
• Collagen-vascular disease
• Allergic reaction to morphine
• Current smokers or alcohol users
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magic mouthwash	Magnesium aluminum hydroxide	The magic group uses a mouthwash contained a mixture of 240 mL magnesium aluminum hydroxide (Alborz Co., Iran), 25 mL 2% viscous lidocaine (SinaDaru Co., Iran), and 60 mL diphenhydramine (Emad Co., Iran), 10 mL every three hours; six times a day.
Morphine mouthwash	2% morphine solution	The morphine group uses the mouthwash of 2% morphine solution (20 mg morphine sulfate diluted in 100 mL of water), 10 mL every three hours; six times a day. The morphine solution is prepared by the faculty of pharmacy under supervision of the Food and Drug Organization of the local Medical University.
Magic mouthwash	2% viscous lidocaine	The magic group uses a mouthwash contained a mixture of 240 mL magnesium aluminum hydroxide (Alborz Co., Iran), 25 mL 2% viscous lidocaine (SinaDaru Co., Iran), and 60 mL diphenhydramine (Emad Co., Iran), 10 mL every three hours; six times a day.
Magic mouthwash	Diphenhydramine	The magic group uses a mouthwash contained a mixture of 240 mL magnesium aluminum hydroxide (Alborz Co., Iran), 25 mL 2% viscous lidocaine (SinaDaru Co., Iran), and 60 mL diphenhydramine (Emad Co., Iran), 10 mL every three hours; six times a day.

Primary Outcome Measures

Name	Time	Method
Mucositis severity	Up to six days	Patients are visited by a radiation oncologist at baseline, 3rd day, and 6th day of the intervention. The WHO grading system of mucositis is administered for each patient in which, 0 indicates a healed mucositis and no signs or symptoms, 1 indicates mild soreness but not problem in eating, 2 indicates painful erythema, edema, or ulcers but able to eat, 3 indicates severe painful erythema, edema, or ulcers and having problem in eating, and 4 indicates if there is a requirement for parenteral or enteral support.

Secondary Outcome Measures

Name	Time	Method
Patient's satisfaction	After six days	Patients also are asked about if pain/discomfort relived by mouthwash and if so for how long (\< 1 h, 1 to 2 h, \> 2 h). Their satisfaction with treatment is graded as satisfied, tolerable, and intolerable.

Trial Locations

Locations (1)

Radiation Oncology Department, Seyed Al-Shohada Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of