Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Phase 2

Completed

• Conditions: Mucositis
• Interventions: Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin); Drug: Bupivacaine

• Registration Number: NCT02252926
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and painful adverse effect caused by the radio therapy and/or chemo therapy patients with head and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the current treatment with opioids is not sufficient and can cause adverse effects.

Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce the oral pain caused by mucositis compared with the current standard treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• diagnosed with head/neck cancer and starting radio therapy treatment
• age between 18 and 80 years (both included)
• able to talk, read and understand Danish
• ability to give informed consent

Exclusion Criteria

• known hypersensitivity towards bupivacaine or other local anesthetics of the amide type
• pregnancy
• women breastfeeding a child

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment	Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)	The patients will be treated with the currently used standard pain treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin). The anesthetics are being administered at the physician's discretion.
Bupivacaine lozenge	Bupivacaine	The patients can take up to eight 25 mg bupivacaine lozenges (max. every second hour in the awake hours) a day for seven days. The patients can use concomitant systemic pain treatment (e.g. morphine).

Primary Outcome Measures

Name	Time	Method
Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)	7 days	The primary outcome measure is the mean VAS score for the patients in the bupivacaine lozenge group compared with the mean VAS score for the patients in the standard treatment group.; The lozenge group measures VAS before and 60 min. after administration of a lozenge for seven days. The standard treatment group measures VAS every second hour for seven days.

Secondary Outcome Measures

Name	Time	Method
Effect of the bupivacaine lozenge	7 days	The difference in pain score (VAS) between the first score in the morning before the first lozenge of the day and the score 60 minuts after the administration of the lozenge. Pain is scored both in the oral cavity and the pharynx.
Safety: Peak plasma concentrations of bupivacaine	90 minutes	The first ten patients receiving the bupivacaine lozenge will on day seven (the last day of their treatment period) get blood samples drawn before a lozenge is administrated and at time 30 min, 60 min. and 90 min. after the administration.
Duration of the effect of the lozenge	7 days	Mean value of the pain score (VAS) measured 120 minuts after the administration of a lozenge for the patients receiving the lozenges compared with the mean value of the pain score (VAS) measured every second hour for the patients receiving the standard treatment.

Trial Locations

Locations (2)

Department of Oncology, Herlev Hospital, Denmark; 🇩🇰 Herlev, Denmark

Department of Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark