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| Name | Class |
|---|---|
| Moberg Pharma, Sweden | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine lozenge | Active Comparator | 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). |
|
| Standard treatment | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 25 mg bupivacaine lozenge |
| |
| Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus A Kristensen, MD, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Jens Bentzen, MD | Department of Oncology Herlev Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Department of Oncology, Herlev Hospital, Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29392234 | Derived | Mogensen S, Treldal C, Kristensen CA, Bentzen J, Lawson-Smith L, Petersen J, Andersen O. Effect of bupivacaine lozenges on oral mucositis pain: a randomized controlled multicenter phase II study. Pain Rep. 2017 Aug 23;2(5):e619. doi: 10.1097/PR9.0000000000000619. eCollection 2017 Sep. |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D009020 | Morphine |
| D000082 | Acetaminophen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin |
|
| 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 |
| Herlev |
| 2730 |
| Denmark |
| D009057 |
| Stomatognathic Diseases |
| D000588 |
| Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |