Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

• Status: Completed
• Trial end date: 2018-08-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ayhman Al Afif
• Collaborator: Nova Scotia Health Authority
• Treatments: Hyaluronic Acid

Criteria

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.