Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

Phase 2

Completed

• Conditions: Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma; Voice Disorders; Laryngeal Cancer
• Interventions: Other: No Hyaluronic Acid Injection Injection; Drug: Hyaluronic acid

• Registration Number: NCT04525066
• Lead Sponsor: Ayhman Al Afif

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-13
• Primary Completion: 2018-08-13
• Study Completion: 2018-08-13
• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group - Not Receiving Hyaluronic Acid Injection	No Hyaluronic Acid Injection Injection	Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
Treatment Group - Receiving Hyaluronic Acid Injection	Hyaluronic acid	Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.

Primary Outcome Measures

Name	Time	Method
Voice Outcome	Changes at 24 months post-operatively compared to baseline.	Maximum Phonation Time

Secondary Outcome Measures

Name	Time	Method
Overall survival	24 months post-augmentation	Kaplan-Meier Survival Analysis
Disease free survival	24 months post-augmentation	Kaplan-Meier Survival Analysis
Recurrence-free survival	24 months post-augmentation	Kaplan-Meier Survival Analysis