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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: University Hospital, Lille

Current Primary Outcome: decreased intensity of pain in referred otalgia [ Time Frame: three weeks ]

diminution of the pain intensity numerical rating scale (NRS)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • neuropathic pain [ Time Frame: Three weeks ]
    diminution of the Neuropathic Pain Scale Inventory (NPSI)
  • Numeric rating Scale [ Time Frame: one, three and six months ]
    referred otalgia after surgery: intensity
  • Neuropathic Pain Symptom Inventory [ Time Frame: one, three and six months ]
    referred otalgia after surgery: presence


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: October 4, 2016
Date Started: June 5, 2015
Date Completion: May 2018
Last Updated: May 17, 2017
Last Verified: May 2017