NCT02252926

Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucositis

Interventions

Type	Name	Description
DRUG	Bupivacaine	25 mg bupivacaine lozenge
DRUG	Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)	Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-09-30
• Last updated: 2016-08-16

Locations

2 sites across 1 country: Denmark