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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Morphine mouthwash

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.

Group Type EXPERIMENTAL

2% morphine solution

Intervention Type DRUG

Magic mouthwash

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.

Group Type ACTIVE_COMPARATOR

Magnesium aluminum hydroxide

Intervention Type DRUG

2% viscous lidocaine

Intervention Type DRUG

Diphenhydramine

Intervention Type DRUG

Interventions

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2% morphine solution

Intervention Type DRUG

Magnesium aluminum hydroxide

Intervention Type DRUG

2% viscous lidocaine

Intervention Type DRUG

Diphenhydramine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No