Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Hvidovre University Hospital

Status and phase: Completed; Phase 2

Conditions: Mucositis

Treatments: Drug: Bupivacaine; Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)

Study type: Interventional

Funder types: Other

Identifiers

NCT02252926

P2HNC01

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Bupivacaine lozenge

Active Comparator group

Description:

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).

Treatment:

Drug: Bupivacaine

Standard treatment

Other group

Description:

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.

Treatment:

Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)