Mucositis
Conditions
Keywords
Anesthetics, Local, Bupivacaine, Lozenge, Administration, Topical
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.
Interventions
DRUGBupivacaine
25 mg bupivacaine lozenge
DRUGStandard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)
Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin
Sponsors
Moberg Pharma, Sweden
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Denmark
Outcome results
None listed