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

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stomatitis

Treatments: Drug: Diphenhydramine; Drug: Magnesium aluminum hydroxide; Drug: 2% viscous lidocaine; Drug: 2% morphine solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01837446

390163

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Morphine mouthwash

Experimental group

Description:

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.

Treatment:

Drug: 2% morphine solution

Magic mouthwash

Active Comparator group

Description:

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.

Treatment:

Drug: 2% viscous lidocaine

Drug: Diphenhydramine

Drug: Magnesium aluminum hydroxide