Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Voice Disorders, Laryngeal Cancer

Intervention / Treatment
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* Drug: Hyaluronic acid
* Other: No Hyaluronic Acid Injection Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group - Receiving Hyaluronic Acid Injection<br>Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer. | Drug: Hyaluronic acid<br>* Patients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.<br>* Other names: Hyaluronic Acid Laryngoplasty;|
| Placebo Comparator: Control Group - Not Receiving Hyaluronic Acid Injection<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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