Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252926
• Other study ID #: P2HNC01
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2014
• Last updated: August 15, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Ethics CommitteeDenmark: Danish Dataprotection AgencyDenmark: The Good Clinical Practice Unit, Copenhagen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mucositis

Intervention

Drug:
• Bupivacaine
25 mg bupivacaine lozenge
• Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)
Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

Locations

Country	Name	City	State
Denmark	Department of Oncology, Rigshospitalet	Copenhagen
Denmark	Department of Oncology, Herlev Hospital, Denmark	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Moberg Pharma, Sweden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)	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.	7 days	No
Secondary	Duration of the effect of the lozenge	Mean value of the pain score (VAS) measured 120 minuts after the administration of a lozenge for the patients receiving the lozenges compared with the mean value of the pain score (VAS) measured every second hour for the patients receiving the standard treatment.	7 days	No
Secondary	Effect of the bupivacaine lozenge	The difference in pain score (VAS) between the first score in the morning before the first lozenge of the day and the score 60 minuts after the administration of the lozenge. Pain is scored both in the oral cavity and the pharynx.	7 days	No
Secondary	Safety: Peak plasma concentrations of bupivacaine	The first ten patients receiving the bupivacaine lozenge will on day seven (the last day of their treatment period) get blood samples drawn before a lozenge is administrated and at time 30 min, 60 min. and 90 min. after the administration.	90 minutes	No