NCT00613743

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

Completed NA Last updated 12 January 2010

What this trial tests

NA trial testing mouth wash with morphine in Cancer in 30 participants. Completed in 1 December 2008.

Timeline

1 December 2007

Primary endpoint
1 January 2008

1 December 2008

Quick facts

Lead sponsor	University Hospital, Geneva
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	1 December 2007
Primary completion	1 January 2008
Estimated completion	1 December 2008
Sites	1 location across Switzerland

Drugs / interventions tested

• mouth wash with morphine — full drug profile →
• placebo

Conditions studied

• Cancer — all drugs for Cancer →
• Mucositis — all drugs for Mucositis →

Sponsor

University Hospital, Geneva

Who can join

18 and older, any sex, with Cancer or Mucositis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Radiation-Induced Oral Mucositis.
   Maria OM, Eliopoulos N, Muanza T. · · 2017 · cited 253× · PMID 28589080 · DOI 10.3389/fonc.2017.00089