NCT01837446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

February 26, 2013

Last Update Submit

April 22, 2013

Conditions

Stomatitis

Keywords

mucositistopical morphinepainhead and neck carcinoma

Outcome Measures

Primary Outcomes (1)

  • Mucositis severity

    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.

    Up to six days

Secondary Outcomes (1)

  • Patient's satisfaction

    After six days

Study Arms (2)

Morphine mouthwash

EXPERIMENTAL

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

Magic mouthwash

ACTIVE COMPARATOR

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 hydroxideDrug: 2% viscous lidocaineDrug: Diphenhydramine

Interventions

2% morphine solutionDRUG
Morphine mouthwash
Magnesium aluminum hydroxideDRUG
Magic mouthwash
2% viscous lidocaineDRUG
Magic mouthwash
DiphenhydramineDRUG
Magic mouthwash

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of severe renal or hepatic insufficiency
  • Collagen-vascular disease
  • Allergic reaction to morphine
  • Current smokers or alcohol users
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Oncology Department, Seyed Al-Shohada Hospital

Isfahan, Isfahan, 81849-17395, Iran

Location

Related Publications (2)

  • Cerchietti LC, Navigante AH, Bonomi MR, Zaderajko MA, Menendez PR, Pogany CE, Roth BM. Effect of topical morphine for mucositis-associated pain following concomitant chemoradiotherapy for head and neck carcinoma. Cancer. 2002 Nov 15;95(10):2230-6. doi: 10.1002/cncr.10938.

    PMID: 12412178BACKGROUND

  • Cerchietti L. Morphine mouthwashes for painful mucositis. Support Care Cancer. 2007 Jan;15(1):115-6; author reply 117. doi: 10.1007/s00520-006-0124-8. Epub 2006 Aug 15. No abstract available.

    PMID: 16909245BACKGROUND

MeSH Terms

Conditions

StomatitisMucositisPain

Interventions

aluminum hydroxide, magnesium hydroxide, drug combinationLidocaineDiphenhydramine

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthylaminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Simin Hemati, MD

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 26, 2013

First Posted

April 23, 2013

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

IR(1)