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Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

Primary Purpose

Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Voice Disorders

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hyaluronic acid
No Hyaluronic Acid Injection Injection
Sponsored by
Ayhman Al Afif
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treatment Group - Receiving Hyaluronic Acid Injection

    Control Group - Not Receiving Hyaluronic Acid Injection

    Arm Description

    Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.

    Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.

    Outcomes

    Primary Outcome Measures

    Voice Outcome
    Voice Handicap Index-10 Scores
    Voice Outcome
    Voice Handicap Index-10 Scores
    Voice Outcome
    Voice Handicap Index-10 Scores
    Voice Outcome
    Maximum Phonation Time
    Voice Outcome
    Maximum Phonation Time
    Voice Outcome
    Maximum Phonation Time

    Secondary Outcome Measures

    Overall survival
    Kaplan-Meier Survival Analysis
    Disease free survival
    Kaplan-Meier Survival Analysis
    Recurrence-free survival
    Kaplan-Meier Survival Analysis

    Full Information

    First Posted
    August 11, 2020
    Last Updated
    August 20, 2020
    Sponsor
    Ayhman Al Afif
    Collaborators
    Nova Scotia Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04525066
    Brief Title
    Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma
    Official Title
    Injection Thyroplasty During Transoral Laser Microsurgery for Early Glottic Cancer: Single-blinded Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 13, 2013 (Actual)
    Primary Completion Date
    August 13, 2018 (Actual)
    Study Completion Date
    August 13, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ayhman Al Afif
    Collaborators
    Nova Scotia Health Authority

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Voice Disorders, Laryngeal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group - Receiving Hyaluronic Acid Injection
    Arm Type
    Experimental
    Arm Description
    Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
    Arm Title
    Control Group - Not Receiving Hyaluronic Acid Injection
    Arm Type
    Placebo Comparator
    Arm Description
    Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic acid
    Other Intervention Name(s)
    Hyaluronic Acid Laryngoplasty
    Intervention Description
    Patients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.
    Intervention Type
    Other
    Intervention Name(s)
    No Hyaluronic Acid Injection Injection
    Intervention Description
    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 Outcome Measure Information:
    Title
    Voice Outcome
    Description
    Voice Handicap Index-10 Scores
    Time Frame
    Change at 3 months post-operatively compared to baseline.
    Title
    Voice Outcome
    Description
    Voice Handicap Index-10 Scores
    Time Frame
    Changes at 12 months post-operatively compared to baseline.
    Title
    Voice Outcome
    Description
    Voice Handicap Index-10 Scores
    Time Frame
    Changes at 24 months post-operatively compared to baseline.
    Title
    Voice Outcome
    Description
    Maximum Phonation Time
    Time Frame
    Changes at 3 months post-operatively compared to baseline.
    Title
    Voice Outcome
    Description
    Maximum Phonation Time
    Time Frame
    Changes at 12 months post-operatively compared to baseline.
    Title
    Voice Outcome
    Description
    Maximum Phonation Time
    Time Frame
    Changes at 24 months post-operatively compared to baseline.
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Description
    Kaplan-Meier Survival Analysis
    Time Frame
    24 months post-augmentation
    Title
    Disease free survival
    Description
    Kaplan-Meier Survival Analysis
    Time Frame
    24 months post-augmentation
    Title
    Recurrence-free survival
    Description
    Kaplan-Meier Survival Analysis
    Time Frame
    24 months post-augmentation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

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