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Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer. (LYRORL)

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ClinicalTrials.gov Identifier: NCT02924675
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

Referred otalgia is one of the symptoms of oropharynx and hypopharynx cancer. It can be primary (otodynia) or secondary (referred otalgia and projected pain). The mechanism of referred otalgia involves several non adjacent nerve territories as those of head, neck or ear. Referred otalgia is a projected pain due to injury (most of the time cancer) localized far from the ear but sharing the same innervation. In this contest, the otoscopy is normal.

Four cranial nerves participate in the sensory innervation of the external ear: the trigeminal nerve (V) via the auriculo temporal nerve (V3), the facial nerve (VII) for the Ramsay-Hunt's zone with the conch, tragus, antitragus, a part of the anthelix, of the external auditory meatus and of the eardrum, the glossopharyngeal nerve (IX) via the Jacobson's nerve for the external ear canal and the C2 and C3 cervical plexus. However, there are important interindividual anatomical variations.

The relationship between referred otalgia and probable nerve damage has been described. In he oropharynx and hypopharynx, the proximity of the sensory innervation of the ear can then explain the otalgia during the cancer progression. Then referred otalgia has a neuropathic component.

In the literature, the curative treatment of referred otalgia is the cancer treatment. However, the high intensity of referred otalgia leads the patients to a large consumption of analgesics in particular of opioids. These latter are particularly adapted for pain resulting from excess of nociceptive stimulation. Pregabalin (Lyrica®) is an analogue of gamma aminobutyric acid. This molecule binds to alpha subunit 2 delta 1 calcium dependent voltage channels in the central nervous system. its effectiveness has been demonstrated for the treatment of neuropathic pain on diabetic neuropathy, post herpetic neuralgia, lesions in the bone marrow but also the postoperative pain when the molecule is administered after the surgery. The anti hyperalgesic activity of pregabalin is at a dosage of 150mg/day in two or three daily doses.

The purpose of this study was to evaluate the activity of pregabalin administered orally for three weeks after the anesthesia consultation on the intensity of the pain of referred otalgia and on its neuropathic component.


Condition or disease Intervention/treatment Phase
Earache Drug: Pregabalin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.
Actual Study Start Date : June 5, 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: pregabalin group Drug: Pregabalin
150mg daily in three doses during three weeks

Placebo Comparator: Placebo group Drug: Placebo
Three doses daily with lactose




Primary Outcome Measures :
  1. decreased intensity of pain in referred otalgia [ Time Frame: three weeks ]
    diminution of the pain intensity numerical rating scale (NRS)


Secondary Outcome Measures :
  1. neuropathic pain [ Time Frame: Three weeks ]
    diminution of the Neuropathic Pain Scale Inventory (NPSI)

  2. Numeric rating Scale [ Time Frame: one, three and six months ]
    referred otalgia after surgery: intensity

  3. Neuropathic Pain Symptom Inventory [ Time Frame: one, three and six months ]
    referred otalgia after surgery: presence



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

Inclusion Criteria:

  • referred otalgia
  • ENT cancer
  • ASA score 1,2 or 3
  • understanding protocol
  • information and free and informed consent

Exclusion Criteria:

  • ASA score 4 et 5
  • allergy or intolerance of pregabalin
  • creatinin clearance inferior of 50ml/min (Cockcroft formula)
  • liver failure
  • cardiac failure
  • history epilepsy
  • ant hyperalgesic treatment
  • minor or disabled adult
  • intellectual disabilities that prevent the understanding of the protocol
  • uncooperative patient
  • pregnant women
  • patient participating in another research protocol
  • lactose intolerant patient

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): NCT02924675


Contacts
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Contact: Gilles Lebuffe, MD,PhD gilles.lebuffe@chru-lille.fr

Locations
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France
CHRU, Hôpital Claude Huriez Recruiting
Lille, France
Principal Investigator: Gilles Lebuffe, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Gilles Lebuffe, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02924675     History of Changes
Other Study ID Numbers: 2013_21
2014-000505-12 ( EudraCT Number )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
neuropathic pain, ent cancer, pregabalin

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Earache
Neoplasms by Site
Neoplasms
Ear Diseases
Otorhinolaryngologic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs