Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Hvidovre University Hospital70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Mucositis

Interventions

BupivacaineDRUG

25 mg bupivacaine lozenge

Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)DRUG

Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Department of Oncology, Rigshospitalet

Copenhagen, Denmark

Department of Oncology, Herlev Hospital, Denmark

Herlev, Denmark

Outcomes

Primary Outcomes

Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)

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.

Time frame: 7 days

Secondary Outcomes

Duration of the effect of the lozenge

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.

Time frame: 7 days

Effect of the bupivacaine lozenge

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.

Time frame: 7 days

Safety: Peak plasma concentrations of bupivacaine

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.

Time frame: 90 minutes

Data from ClinicalTrials.gov

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