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| Name | Class |
|---|---|
| Nova Scotia Health Authority | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group - Receiving Hyaluronic Acid Injection | Experimental | Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer. |
|
| Control Group - Not Receiving Hyaluronic Acid Injection | Placebo Comparator | Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid | Drug | Patients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Kaplan-Meier Survival Analysis | 24 months post-augmentation |
| Disease free survival | Kaplan-Meier Survival Analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D014832 | Voice Disorders |
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| No Hyaluronic Acid Injection Injection | Other | 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. |
|
| 24 months post-augmentation |
| Recurrence-free survival | Kaplan-Meier Survival Analysis | 24 months post-augmentation |
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D012142 | Respiratory Tract Neoplasms |