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Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

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ClinicalTrials.gov Identifier: NCT02252926
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : August 16, 2016
Sponsor:
Collaborator:
Moberg Pharma, Sweden
Information provided by (Responsible Party):
Claus Andrup Kristensen, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Mucositis Drug: Bupivacaine Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252926


Locations
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Denmark
Department of Oncology, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Oncology, Herlev Hospital, Denmark
Herlev, Denmark, 2730
Sponsors and Collaborators
Hvidovre University Hospital
Moberg Pharma, Sweden
Investigators
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Principal Investigator: Claus A Kristensen, MD, PhD Department of Oncology, Rigshospitalet, Denmark
Principal Investigator: Jens Bentzen, MD Department of Oncology, Herlev Hospital, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Claus Andrup Kristensen, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02252926     History of Changes
Other Study ID Numbers: P2HNC01
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by Claus Andrup Kristensen, Rigshospitalet, Denmark:
Anesthetics, Local
Bupivacaine
Lozenge
Administration, Topical

Additional relevant MeSH terms:
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Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Bupivacaine
Lidocaine
Anesthetics, Local
Anesthetics
Morphine
Gabapentin
Acetaminophen
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Anticonvulsants
Anti-Anxiety Agents