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

18 Years
Not Enrolling
Cancer, Mucositis

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Sophie Pautex, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Geneva


Switzerland: institut suisse produits thérapeutiques

Study ID:




Start Date:

December 2007

Completion Date:

December 2008

Related Keywords:

  • Cancer
  • Mucositis
  • Mucositis