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Completed

NCT Number: NCT04525066

Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

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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Key information

Conditions

Head and Neck Neoplasms Carcinoma Carcinoma, Squamous Cell Head and Neck Squamous Cell Carcinoma Laryngeal Cancer Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Squamous Cell Carcinoma of Head and Neck Voice Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Hyaluronic Acid Laryngoplasty

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.

Primary outcomes

  1. Voice Outcome

    Time frame: Change at 3 months post-operatively compared to baseline.

    Voice Handicap Index-10 Scores

  2. Voice Outcome

    Time frame: Changes at 12 months post-operatively compared to baseline.

    Voice Handicap Index-10 Scores

  3. Voice Outcome

    Time frame: Changes at 24 months post-operatively compared to baseline.

    Voice Handicap Index-10 Scores

  4. Voice Outcome

    Time frame: Changes at 3 months post-operatively compared to baseline.

    Maximum Phonation Time

  5. Voice Outcome

    Time frame: Changes at 12 months post-operatively compared to baseline.

    Maximum Phonation Time

  6. Voice Outcome

    Time frame: Changes at 24 months post-operatively compared to baseline.

    Maximum Phonation Time

Secondary outcomes

  1. Overall survival

    Time frame: 24 months post-augmentation

    Kaplan-Meier Survival Analysis

  2. Disease free survival

    Time frame: 24 months post-augmentation

    Kaplan-Meier Survival Analysis

  3. Recurrence-free survival

    Time frame: 24 months post-augmentation

    Kaplan-Meier Survival Analysis

Sponsors and collaborators

Lead sponsor

Ayhman Al Afif

Other

Collaborators

  • Nova Scotia Health Authority

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 25, 2020
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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