Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT01837446|
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Stomatitis||Drug: 2% morphine solution Drug: Magnesium aluminum hydroxide Drug: 2% viscous lidocaine Drug: Diphenhydramine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|Study Start Date :||July 2011|
|Primary Completion Date :||July 2012|
|Study Completion Date :||October 2012|
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|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|