Effect of Topical Morphine (Mouthwash) on Oral Pain Due to Chemo- and/or Radiotherapy Induced Mucositis

NCT00613743 | Completed DMC

• 1 other identifier: 06-165/psy06-033
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Oral pain due to mucosal lesion is quite frequent in oncology, geriatric as well as palliative care settings. The oncology patient is mainly suffering from radio- and/or chemotherapy induced oral mucositis. The incidence of oral mucositis in oncology patients ranges from 15-40% in those receiving stomatotoxic chemotherapy or radiotherapy. The degree of mucositis is variable, but the associated pain is frequent and well documented. Nowadays, basic oral care protocols are the mainstay of preventing or reducing mucositis pain. Pain is mainly managed by systemically administered analgesia. The only pioneer work in the field of radio-or chemotherapy induced mucositis treatment with topical opioids has been done by Cerchietti in two pilot studies: one compared "magic" mouthwash (lidocaine, diphenhydramine, magnesium aluminium hydroxide) with morphine mouthwash in a randomized trial; the other compared 1%o and 2% morphine solutions in an open trial. The results showed a significant decrease in the duration of pain, the intensity as well as a decrease the need for systemic analgesia in the group with morphine mouthwash. No systemic clinically relevant adverse effects were noted. Hypothesis: Mouthwashes with a morphine containing solution decrease oral pain substantially, while not causing the side effects seen in systemic administration of narcotic analgesics. Method: A randomised double-blind cross-over study to evaluate the effect of topical oral application of a 0.2% morphine solution in patients suffering from radio- and/or chemotherapy induced oral mucositis. 60 patients will be included. Randomly assigned to either the morphine solution or a placebo mouthwash, they receive the first three days one of the solutions and then are switched over to the other treatment for three more days. General basic oral care is offered to all of the patients. Efficacy of treatment will be measured with a self-assessment pain scale. Doses of systemic opioids and other symptoms (appetite, dysphagia) will also be measured. If patient's don't receive systemic opioids, serum concentrations of morphine will be measured.

Conditions

Cancer; Mucositis

Outcome Measures

Primary Outcomes (1)

• difference of pain alleviation in the two branches one hour after mouthwash and as well as the duration of pain relief.

  1 year

Secondary Outcomes (1)

• the requirement of supplementary systemic analgesics

  1 year

Study Arms (2)

1

PLACEBO COMPARATOR

D1-D3 receive placebo

Drug: placebo

2

ACTIVE COMPARATOR

receive D1 D3 morphine

Drug: mouth wash with morphine

Interventions

mouth wash with morphine DRUG

morphine solution 0.2% concentration; 15ml per unit mouthwash 6 time à day

2

placebo DRUG

placebo solution Quinine diHCl 0.3% at 50 mg/15 ml mouthwash 6 time/day

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalised patients, or ambulatory patients that have daily radiotherapy in HUG
• Treatment with chemo- and/or radiotherapy causing oral mucositis
• Oral pain associated with mucosal injury (WHO grading of mucositis \>= 2)
• Cognition: Mini Mental Status Examination of at least 28/30

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital Geneva

Geneva, Collonge-bellerive, 1245, Switzerland

Location

MeSH Terms

Conditions

Neoplasms; Mucositis

Interventions

Mouthwashes; Morphine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sophie Pautex, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: December 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 13, 2010

Record last verified: 2008-01

Locations

CH (1)