Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

Injection Thyroplasty During Transoral Laser Microsurgery for Early Glottic Cancer: Single-blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525066
• Other study ID #: 1020322
• Status: Completed
• Phase: Phase 2
• Start date: August 13, 2013
• Est. completion date: August 13, 2018

Study information

• Verified date: August 2020
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Laryngeal Cancer
• Laryngeal Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• Voice Disorders

Intervention

Drug:
• Hyaluronic 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.

Other:
• No 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ayhman Al Afif	Nova Scotia Health Authority

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voice Outcome	Voice Handicap Index-10 Scores	Change at 3 months post-operatively compared to baseline.
Primary	Voice Outcome	Voice Handicap Index-10 Scores	Changes at 12 months post-operatively compared to baseline.
Primary	Voice Outcome	Voice Handicap Index-10 Scores	Changes at 24 months post-operatively compared to baseline.
Primary	Voice Outcome	Maximum Phonation Time	Changes at 3 months post-operatively compared to baseline.
Primary	Voice Outcome	Maximum Phonation Time	Changes at 12 months post-operatively compared to baseline.
Primary	Voice Outcome	Maximum Phonation Time	Changes at 24 months post-operatively compared to baseline.
Secondary	Overall survival	Kaplan-Meier Survival Analysis	24 months post-augmentation
Secondary	Disease free survival	Kaplan-Meier Survival Analysis	24 months post-augmentation
Secondary	Recurrence-free survival	Kaplan-Meier Survival Analysis	24 months post-augmentation