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NCT Number: NCT02252926

Local Anesthetic Treatment of Oral Pain in Patients With 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.

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Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

25 mg bupivacaine lozenge

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

Drug

Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Moberg Pharma, Sweden

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2014
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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