Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

Ayhman Al Afif

Status and phase: Completed; Phase 2

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

Treatments: Drug: Hyaluronic acid; Other: No Hyaluronic Acid Injection Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04525066

1020322

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups, including a placebo group

Treatment Group - Receiving Hyaluronic Acid Injection

Experimental group

Description:

Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.

Treatment:

Drug: Hyaluronic acid

Control Group - Not Receiving Hyaluronic Acid Injection

Placebo Comparator group

Description:

Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.

Treatment:

Other: No Hyaluronic Acid Injection Injection