Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer
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.
Drug: 2% morphine solution
Drug: Magnesium aluminum hydroxide
Drug: 2% viscous lidocaine
|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|
- 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.
- 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.
|Study Start Date:||July 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01837446
|Iran, Islamic Republic of|
|Radiation Oncology Department, Seyed Al-Shohada Hospital|
|Isfahan, Iran, Islamic Republic of, 81849-17395|
|Principal Investigator:||Simin Hemati, MD||Isfahan University of Medical Sciences|