Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Collaborator: Moberg Pharma, Sweden
• Treatments: Acetaminophen; Anesthetics; Anesthetics, Local; Bupivacaine; Gabapentin; Lidocaine; Morphine; Pharmaceutical Solutions

Criteria

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