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Completed

NCT Number: NCT01837446

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.

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Key information

Conditions

Stomatitis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Radiation Oncology Department, Seyed Al-Shohada Hospital

Isfahan, 81849-17395, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% morphine solution

Drug

Magnesium aluminum hydroxide

Drug

2% viscous lidocaine

Drug

diphenhydramine

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 23, 2013
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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