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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00613743
First received: January 31, 2008
Last updated: January 12, 2010
Last verified: January 2008

January 31, 2008
January 12, 2010
December 2007
January 2008   (final data collection date for primary outcome measure)
difference of pain alleviation in the two branches one hour after mouthwash and as well as the duration of pain relief. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00613743 on ClinicalTrials.gov Archive Site
the requirement of supplementary systemic analgesics [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Topical Morphine (Mouthwash) on Oral Pain Due to Chemo- and/or Radiotherapy Induced Mucositis
Effect of Topical Morphine (Mouthwash) on Oral Pain Due to Chemo- and/or Radiotherapy Induced Mucositis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cancer
  • Mucositis
  • Drug: mouth wash with morphine
    morphine solution 0.2% concentration; 15ml per unit mouthwash 6 time à day
  • Drug: placebo
    placebo solution Quinine diHCl 0.3% at 50 mg/15 ml mouthwash 6 time/day
  • Placebo Comparator: 1
    D1-D3 receive placebo
    Intervention: Drug: placebo
  • Active Comparator: 2
    receive D1 D3 morphine
    Intervention: Drug: mouth wash with morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00613743
06-165/psy06-033
Yes
Pautex Sophie, university hospital geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Sophie Pautex, MD University Hospital, Geneva
University Hospital, Geneva
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP