Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Laryngeal Cancer, Voice Disorders
Conditions
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.
Interventions
DRUGHyaluronic 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.
OTHERNo 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.
Sponsors
Nova Scotia Health Authority
Ayhman Al Afif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Voice Outcome | Change at 3 months post-operatively compared to baseline. | Voice Handicap Index-10 Scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed