Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer. (LYRORL)
Primary Purpose
Earache
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Earache focused on measuring neuropathic pain, ent cancer, pregabalin
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
Sites / Locations
- CHRU, Hôpital Claude Huriez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
pregabalin group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
decreased intensity of pain in referred otalgia
diminution of the pain intensity numerical rating scale (NRS)
Secondary Outcome Measures
neuropathic pain
diminution of the Neuropathic Pain Scale Inventory (NPSI)
Numeric rating Scale
referred otalgia after surgery: intensity
Neuropathic Pain Symptom Inventory
referred otalgia after surgery: presence
Full Information
NCT ID
NCT02924675
First Posted
October 4, 2016
Last Updated
October 10, 2019
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT02924675
Brief Title
Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.
Acronym
LYRORL
Official Title
Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
not sufficiency recruitment
Study Start Date
June 5, 2015 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Earache
Keywords
neuropathic pain, ent cancer, pregabalin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pregabalin group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
150mg daily in three doses during three weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Three doses daily with lactose
Primary Outcome Measure Information:
Title
decreased intensity of pain in referred otalgia
Description
diminution of the pain intensity numerical rating scale (NRS)
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
neuropathic pain
Description
diminution of the Neuropathic Pain Scale Inventory (NPSI)
Time Frame
Three weeks
Title
Numeric rating Scale
Description
referred otalgia after surgery: intensity
Time Frame
one, three and six months
Title
Neuropathic Pain Symptom Inventory
Description
referred otalgia after surgery: presence
Time Frame
one, three and six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Lebuffe, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.
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