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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Simin Hemati, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01837446
First received: February 26, 2013
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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
Stomatitis
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Mucositis severity [ Time Frame: Up to six days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837446

Locations
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
Investigators
Principal Investigator: Simin Hemati, MD Isfahan University of Medical Sciences
  More Information

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

Keywords provided by Isfahan University of Medical Sciences:
mucositis
topical morphine
pain
head and neck carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Neoplasms
Neoplasms by Site
Stomatognathic Diseases
Aluminum Hydroxide
Aluminum hydroxide, magnesium hydroxide, drug combination
Diphenhydramine
Lidocaine
Magnesium Hydroxide
Morphine
Pharmaceutical Solutions
Promethazine
Adjuvants, Immunologic
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, Local
Antacids
Anti-Allergic Agents
Anti-Arrhythmia Agents
Antiemetics
Antipruritics
Autonomic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on November 23, 2014