Clinical trial NCT02924675: Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.
Official title: Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Earache
Keywords: neuropathic pain, ent cancer, pregabalin
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: decreased intensity of pain in referred otalgia
timeFrame: three weeks
Secondary outcomes:
measure: neuropathic pain
timeFrame: Three weeks
measure: Numeric rating Scale
timeFrame: one, three and six months
measure: Neuropathic Pain Symptom Inventory
timeFrame: one, three and six months
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Gilles Lebuffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: