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

NCT ID: NCT00613743

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-12-31

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.

Detailed Description

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

D1-D3 receive placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

2

receive D1 D3 morphine

Group Type: ACTIVE_COMPARATOR

mouth wash with morphine

Intervention Type: DRUG

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

Interventions

mouth wash with morphine

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Hospitalised patients, or ambulatory patients that have daily radiotherapy in HUG
• No risk of swallowing the mouth wash solution (determined before inclusion by a recovery of more than 90% of the 15ml of water solution used for testing)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

university hospital geneva

Principal Investigators

Sophie Pautex, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

University Hospital Geneva

Geneva, Collonge-bellerive, Switzerland

Countries

Switzerland

Other Identifiers

06-165/psy06-033

Identifier Type: -

Identifier Source: org_study_id