Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

August 20, 2020 updated by: Ayhman Al Afif

Injection Thyroplasty During Transoral Laser Microsurgery for Early Glottic Cancer: Single-blinded Randomized Controlled Trial

Objectives: Transoral Laser Microsurgery (TLM) is widely used in for treating T1/T2 glottic cancers. Hyaluronic acid (HA) is a safe and commonly-used injectable in vocal cord augmentation. We report on the results of our single-blinded, randomized-controlled trial (RCT) investigating the impact of intra-operative HA injection on voice outcomes in early glottic cancer.

Methods: Patients with T1/T2 glottic cancers were randomized to the treatment group (n=14) receiving HA injection to the unaffected cord during TLM; or the control group, receiving no injection (n=16). All patients had a Voice Handicap Index-10 (VHI-10) questionnaire and a Maximum Phonation Time (MPT) measurement preoperatively and at 3, 12 and 24 months post-operatively. Mean change in VHI-10 and MPT, between pre-operative and post-operative time points, and between the time points, were compared. Survival estimates were also calculated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females
  • 18 years of age or older with a biopsy-proven T1a, T1b or T2 glottic SCC
  • Lesion amenable to CO2 TLM resection.

Exclusion Criteria:

  • Previous radiotherapy to the head and neck.
  • Palpable, or radiographic, pathological lymphadenopathy.
  • Allergy, or sensitivity, to HA or components of the injectable.
  • Neurological disorder affecting phonation, such as multiple sclerosis or stroke.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group - Receiving Hyaluronic Acid Injection
Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
Drug: Hyaluronic acid
Patients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.
Other Names:
  • Hyaluronic Acid Laryngoplasty
Placebo Comparator: Control Group - Not Receiving Hyaluronic Acid Injection
Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
Other: No Hyaluronic Acid Injection Injection
Patients in the placebo group did not receive hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice Outcome
Time Frame: Change at 3 months post-operatively compared to baseline.
Voice Handicap Index-10 Scores
Change at 3 months post-operatively compared to baseline.
Voice Outcome
Time Frame: Changes at 12 months post-operatively compared to baseline.
Voice Handicap Index-10 Scores
Changes at 12 months post-operatively compared to baseline.
Voice Outcome
Time Frame: Changes at 24 months post-operatively compared to baseline.
Voice Handicap Index-10 Scores
Changes at 24 months post-operatively compared to baseline.
Voice Outcome
Time Frame: Changes at 3 months post-operatively compared to baseline.
Maximum Phonation Time
Changes at 3 months post-operatively compared to baseline.
Voice Outcome
Time Frame: Changes at 12 months post-operatively compared to baseline.
Maximum Phonation Time
Changes at 12 months post-operatively compared to baseline.
Voice Outcome
Time Frame: Changes at 24 months post-operatively compared to baseline.
Maximum Phonation Time
Changes at 24 months post-operatively compared to baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 24 months post-augmentation
Kaplan-Meier Survival Analysis
24 months post-augmentation
Disease free survival
Time Frame: 24 months post-augmentation
Kaplan-Meier Survival Analysis
24 months post-augmentation
Recurrence-free survival
Time Frame: 24 months post-augmentation
Kaplan-Meier Survival Analysis
24 months post-augmentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayhman Al Afif

Collaborators

Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2013

Primary Completion (Actual)

August 13, 2018

Study Completion (Actual)

August 13, 2018

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1020322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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