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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01837446

Enrollment

Registered

2013-04-23

Start date

2011-07-31

Completion date

2012-10-31

Last updated

2013-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomatitis

Keywords

mucositis, topical morphine, pain, head and neck carcinoma

Brief summary

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.

Interventions

DRUG2% morphine solution

DRUGMagnesium aluminum hydroxide

DRUG2% viscous lidocaine

DRUGDiphenhydramine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mucositis severity	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

Measure	Time frame	Description
Patient's satisfaction	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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026