Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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).
Intervention: Bupivacaine (Drug)
Standard treatment
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.
Intervention: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin) (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Effect of the bupivacaine lozenge(7 days)
- Safety: Peak plasma concentrations of bupivacaine(90 minutes)
- Duration of the effect of the lozenge(7 days)
Investigators
Claus Andrup Kristensen
MD, PhD
Rigshospitalet, Denmark