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

This study has been completed.
Information provided by (Responsible Party):
Dr. Simin Hemati, Isfahan University of Medical Sciences Identifier:
First received: February 26, 2013
Last updated: April 22, 2013
Last verified: April 2013
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.

Condition Intervention Phase
Drug: 2% morphine solution
Drug: Magnesium aluminum hydroxide
Drug: 2% viscous lidocaine
Drug: Diphenhydramine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of Topical Morphine Compared With a Routine Mouthwash in Managing Cancer Treatment-induced Mucositis in Patients With Head and Neck Cancer in Isfahan

Resource links provided by NLM:

Further study details as provided by Dr. Simin Hemati, Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Mucositis severity [ Time Frame: 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:
  • Patient's satisfaction [ Time Frame: 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.

Enrollment: 30
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 2% morphine solution
Active Comparator: 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.
Drug: Magnesium aluminum hydroxide Drug: 2% viscous lidocaine Drug: Diphenhydramine


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01837446

Iran, Islamic Republic of
Radiation Oncology Department, Seyed Al-Shohada Hospital
Isfahan, Iran, Islamic Republic of, 81849-17395
Sponsors and Collaborators
Isfahan University of Medical Sciences
Principal Investigator: Simin Hemati, MD Isfahan University of Medical Sciences
  More Information

Responsible Party: Dr. Simin Hemati, Dr., Isfahan University of Medical Sciences Identifier: NCT01837446     History of Changes
Other Study ID Numbers: 390163
Study First Received: February 26, 2013
Last Updated: April 22, 2013

Keywords provided by Dr. Simin Hemati, Isfahan University of Medical Sciences:
topical morphine
head and neck carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Aluminum hydroxide, magnesium hydroxide, drug combination
Aluminum Hydroxide
Magnesium Hydroxide
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators processed this record on May 25, 2017