Trial with lozenges as local pain treatment for head and neck cancer patients with oral inflammatio

Phase 1

Conditions: Oral pain due to oral mucositis in head and neck cancer patients which are undergoing radiation therapy
MedDRA version: 17.1Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 100000004856
MedDRA version: 17.1Level: PTClassification code 10037763Term: Radiation mucositisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-002346-42-DK

Lead Sponsor: Copenhagen University Hospital, Hvidovre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Diagnosed with head and neck cancer and scheduled for radiation therapy
- Age between 18 and 80
- Be able to speak, read and understand danish
- Be able to give informed written consent
- Be able to use an electronic media with a touch screen, such as a smart phone or a tablet PC

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Known allergy to bupivacaine or other local analgesia of the amid type
- Pregnancy
- Breast feeding women
- Use of opioid pain treatment before start of radiation treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if bupivacaine lozenges are an effective and patient friendly pain treatment for oral pain in head and neck cancer patients with oral mucositis and thereby reduce the need for opioids as pain treatment in this patient group compared to standard pain treatment.;Secondary Objective: Reduction of the use of opioids as additional pain treatment in the lozenge group compared to standard treatment group;Primary end point(s): Measurement of the oral pain on a visual analogue scale from 0-100 mm, where 0 = no pain and 100 = worst thinkable oral pain ;Timepoint(s) of evaluation of this end point: The patient has to measure VAS before administration of each bupivacaine lozenge and 60 minutes after. In the control group will VAS be measured every 2 hours.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Reduction of the patient’s opioid use in the lozenge group compared to the opioid use in the control group measured in mg/day<br>- Reduction in days on opiods in the trial period for the lozenge group compared to the control group.<br>;Timepoint(s) of evaluation of this end point: End of trial