Clinical trial NCT02973152: Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.
Official title: Does Laryngeal Reinnervation or Type I Thyroplasty Give Better Voice Results for Patients With Unilateral Vocal Fold Paralysis (VOCALIST): a Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vocal Cord Paralysis Unilateral
Keywords: Type I Thyroplasty
Reinnervation
Lead sponsor: Royal National Throat, Nose and Ear Hospital
Sponsor class: OTHER
Collaborators: name: University College Joint Research Office
name: University College London Hospitals
name: NIHR Research for Patient Benefit (RfPB)
name: Sealed Envelope: Redpill Online Application
First posted: 2016-11-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to help determine the most effective treatment for participants with Unilateral Vocal Fold Paralysis.

There are currently two types of operations used to treat this condition. One operation is called thyroplasty. Doctors place a small piece of safe plastic into the side of the participant's voice box to push the weak vocal cord into a position to enable better speech and swallowing. In the other operation called laryngeal reinnervation, doctors repair the neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better speech and swallowing. The investigators do not know which of these methods is better and are conducting this study to start comparing the two operations so that a larger clinical trial can be conducted in the future to tell us which operation is best.

Detailed description: Title: Does Laryngeal Reinnervation or Type I Thyroplasty give better voice results for patients with Unilateral Vocal Fold Paralysis (VOCALIST): a feasibility study

Short title: VOCALIST

Trial medication: Not Applicable

Phase of trial: Phase IIb

Objectives: The aim of the study is to establish the feasibility of a multicentre, randomised phase III clinical trial of surgical treatment for Unilateral Vocal Fold Paralysis (UVFP).

Main objectives are to test the feasibility of:

1. the multicentre recruitment process, including continuous improvement to the process based on qualitative analysis;
2. recruiters being able to present true equipoise with the treatment arms;
3. the randomisation process and investigate reasons for any difficulties that affect recruitment
4. the utility of the following characteristics of the proposed primary (voice handicap index) and secondary outcomes: variability across patients, variability over time, differences in outcome between randomised groups over time;
5. process of follow up visits and diary completion;
6. means of gathering health economics and health-related quality of life data suitable for measuring cost effectiveness.

Type of trial: Quantitative and Qualitative Feasibility Study; multi-centre randomised controlled trial

Trial design and methods: 30 patients will be randomised to receive the Laryngeal Reinnervation or Type I Thyroplasty surgery.

Trial duration per participant: 12 months

Estimated total trial duration: 24 months

Planned trial sites: Multi-site; London, Poole and Manchester (3 sites).

Total number of participants planned: 30

Statistical methodology and analysis: The trial analysis will be descriptive and will be performed on an intention to treat basis. Primary and secondary outcomes will be described using proportions and means as appropriate, with confidence intervals. No formal comparisons will be made. The correlations between the voice outcome measures will be calculated. There is no planned interim analysis.

Eligibility criteria: Inclusion Criteria:

* UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin of between 6 and 60 months duration. Or symptoms that have not sufficiently improved with speech therapy alone, as determined by the patient and agreed by a multidisciplinary clinical team, after 6 months and pending a surgical decision.
* Age from 18 to 70 years old
* Male or female
* Able to provide informed consent
* A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-10 score \>16)
* Common laryngeal electromyography (EMG, neurophysiological) criteria (Koufman Grades 2-5) in either the thyroarytenoid (TA) or posterior cricoarytenoid (PCA) muscle on the paralysed side.

Exclusion Criteria:

* Impaired vocal fold mobility but a normal EMG (Koufman Grade I)
* Severe lung disorders
* Structural vocal fold lesions such as polyp
* Previous laryngeal framework surgery
* Cricoarytenoid joint fixation (CAJF)
* Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
* Previous Level 2, 3 or 4 thyroid neck dissection
* Previous ipsilateral surgical neck dissection
* Previous radiotherapy to the head and neck
* Laryngeal injection of a rapidly absorbable material in the last 6 months.
* Previous laryngeal injection of a non-rapidly absorbable material (e.g. bioplastics, VOX)
* Neuromuscular disease affecting the larynx or multiple cranial nerve palsies

Primary outcomes:
measure: Whether the participant was randomised (yes/no)
timeFrame: 24 months
measure: Whether the participant successfully received the allocated operation (yes/no)
timeFrame: 24 months
measure: Whether the participant completed the trial (yes/no)
timeFrame: 24 months
Secondary outcomes:
measure: Whether the Study Management Group (SMG) and recruiters are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews.
timeFrame: 24 months
measure: Whether surgeons and speech therapists are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews. between the two treatments
timeFrame: 24 months
measure: Patient views and beliefs on randomisation, recruitment and retention measured by Qualitative researcher via interviews. processes
timeFrame: 24 months
measure: Patient and surgeon/speech therapist views on utility of chosen outcome measure measured by Qualitative researcher via interviews. measures
timeFrame: 24 months
measure: Interaction between recruiter and patient during recruitment process measured by Qualitative researcher via interviews.
timeFrame: 24 months
measure: The validated EQ-5D-5L questionnaire will be used to evaluate the participants' health-related quality of life
timeFrame: Baseline, 6 months and 12 month post surgery
measure: The validated VHI-10 [134] will be used to evaluate the psychosocial effects of voice disorder.
timeFrame: Baseline, 6 months and 12 month post surgery
measure: The validated Eating Assessment Tool (EAT-10) [1920] will be used to evaluate the effects of swallowing.
timeFrame: Baseline, 6 months and 12 month post surgery
measure: The Stroboscopy Research Instrument (SRI) scale will be used to rate the Vocal cord vibration.
timeFrame: Baseline, 6 months and 12 month post surgery
measure: Perceptual voice quality analysis will be determined using the GRBAS scale.
timeFrame: Baseline, 6 months and 12 month post surgery
measure: The OperaVOX™ system will also be used to perform the acoustic voice analysis.
timeFrame: Baseline, 6 months and 12 month post surgery
measure: The validated 100ml Water Swallow test will be used to measure the participants' swallowing.
timeFrame: Baseline, 6 months and 12 month post surgery
measure: Laryngeal EMG will be used to detect laryngeal muscle activity.
timeFrame: Baseline, 6 months and 12 month post surgery
measure: Cost of laryngeal reinnervation versus thyroplasty procedures for unilateral vocal fold paralysis.
timeFrame: 24 months
measure: Lifetime incremental cost per quality-adjusted life year QALY gained of laryngeal reinnervation versus thyroplasty.
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road
Study officials:
affiliation: University College London Hospitals
name: Professor Martin Birchall, FRCS,FMedSci
role: PRINCIPAL_INVESTIGATOR
References: