Local Anesthetic Treatment of Oral Pain in Patients With Mucositis
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|ClinicalTrials.gov Identifier: NCT02252926|
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : August 16, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Mucositis||Drug: Bupivacaine Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Bupivacaine lozenge
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).
25 mg bupivacaine lozenge
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)
Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin
- Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS) [ Time Frame: 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.
- Duration of the effect of the lozenge [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252926
|Department of Oncology, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Department of Oncology, Herlev Hospital, Denmark|
|Herlev, Denmark, 2730|
|Principal Investigator:||Claus A Kristensen, MD, PhD||Department of Oncology, Rigshospitalet, Denmark|
|Principal Investigator:||Jens Bentzen, MD||Department of Oncology, Herlev Hospital, Denmark|