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

NCT02924675 | Terminated Phase 2

• 2 other identifiers: 2013_212014-000505-12
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Earache

Keywords

neuropathic pain, ent cancer, pregabalin

Outcome Measures

Primary Outcomes (1)

• decreased intensity of pain in referred otalgia

  diminution of the pain intensity numerical rating scale (NRS)

  three weeks

Secondary Outcomes (3)

• neuropathic pain

  Three weeks

• Numeric rating Scale

  one, three and six months

• Neuropathic Pain Symptom Inventory

  one, three and six months

Study Arms (2)

pregabalin group

EXPERIMENTAL

Drug: Pregabalin

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregabalin DRUG

150mg daily in three doses during three weeks

pregabalin group

Placebo DRUG

Three doses daily with lactose

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

MeSH Terms

Conditions

Earache; Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Gilles Lebuffe, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: June 5, 2015
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: October 14, 2019

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)