Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Digestive System Diseases

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Pain

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

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Anti-Arrhythmia Agents

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Lidocaine

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Aluminum hydroxide, magnesium hydroxide, drug combination

Magnesium Hydroxide

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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.

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.

2% morphine solution

Magnesium aluminum hydroxide

2% viscous lidocaine

Simin Hemati, MD

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.

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

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

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.

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.

Isfahan University of Medical Sciences

Wounds and Injuries

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Cancer Pain

Chronic Pain

Ulcer

Skin Ulcer

Neurologic Manifestations

Chronic Graft Versus Host Disease

topical morphine

Pesach Shvartzman, Professor

Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high systemic dosages of opioids. Yet, many patients continue to report pain while experiencing dose-limiting side effects. An alternative approach to systemic administration is to apply topical medications. The advantage of topical application is the potential of achieving good analgesia using low dosages with few, if any, systemic side effects. Current clinical data indicates, that topically applied morphine has an analgesic effect in patients with severe pain and that it may even improve wound healing. The clinical reports so far have been either case studies or double blind randomly controlled trials with a very small sample size of patients. There is still a great deal of information which is lacking about this modality of treatment regarding on the one hand, the mechanism of action and on the other, clinical issues. For example, is the mechanism of the effect actually peripheral? What is the adequate dose of analgesic medication for different types of skin conditions? Wound healing has not been quantified.

We will apply morphine topically to skin wounds of cancer and evaluate the effect of the treatment on pain, side effects, quantify wound healing, quantify morphine and its metabolites in blood and urine.

Should well controlled studies, demonstrate all or any of the peripheral effects of topical morphine, clinical application of this treatment modality would be possible. This could contribute towards better treatment of these patients, who have pain which is difficult to treat and can, at times, be intractable.

Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain

Israel Cancer Association

Soroka University Medical Center

Head-Department of Family Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer	NCT01837446	Stomatitis	2% morphine sol... Magnesium alumi... 2% viscous lido... Diphenhydramine	18 Years -	Isfahan University of Medical Sciences
Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer	NCT01837446	Stomatitis	2% morphine sol... Magnesium alumi... 2% viscous lido... Diphenhydramine	18 Years -	Isfahan University of Medical Sciences
Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain	NCT00306020	Ulcer Wounds and Inju...	topical morphin...	18 Years - 75 Years	Soroka University Medical Center
Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer	NCT01837446	Stomatitis	2% morphine sol... Magnesium alumi... 2% viscous lido... Diphenhydramine	18 Years -	Isfahan University of Medical Sciences

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