Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

August 15, 2016 updated by: Claus Andrup Kristensen, Hvidovre University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Oncology, Rigshospitalet
      • Herlev, Denmark, 2730
        • Department of Oncology, Herlev Hospital, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Drug: Bupivacaine
25 mg bupivacaine lozenge
Other: 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.
Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)
Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the effect of the lozenge
Time Frame: 7 days
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
Effect of the bupivacaine lozenge
Time Frame: 7 days
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
Safety: Peak plasma concentrations of bupivacaine
Time Frame: 90 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Moberg Pharma, Sweden

Investigators

  • Principal Investigator: Claus A Kristensen, MD, PhD, Department of Oncology, Rigshospitalet, Denmark
  • Principal Investigator: Jens Bentzen, MD, Department of Oncology Herlev Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 26, 2014

First Posted (Estimate)

September 30, 2014

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2HNC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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