Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis

Conditions
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Mucositis

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine lozenge<br>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). | Drug: Bupivacaine<br>* 25 mg bupivacaine lozenge<br>|
| Other: Standard treatment<br>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. | Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)<br>* Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetics, Local, Bupivacaine, Lozenge, Administration, Topical