NCT04525066

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

5 years

First QC Date

August 11, 2020

Last Update Submit

August 20, 2020

Conditions

Head and Neck NeoplasmsHead and Neck Squamous Cell CarcinomaVoice DisordersLaryngeal Cancer

Outcome Measures

Primary Outcomes (6)

  • 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.

Secondary Outcomes (3)

  • Overall survival

    24 months post-augmentation

  • Disease free survival

    24 months post-augmentation

  • Recurrence-free survival

    24 months post-augmentation

Study Arms (2)

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.

Drug: Hyaluronic acid

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.

Other: No Hyaluronic Acid Injection Injection

Interventions

Hyaluronic acidDRUG

Patients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.

Also known as: Hyaluronic Acid Laryngoplasty
Treatment Group - Receiving Hyaluronic Acid Injection
No Hyaluronic Acid Injection InjectionOTHER

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.

Control Group - Not Receiving Hyaluronic Acid Injection

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females
  • years of age or older with a biopsy-proven T1a, T1b or T2 glottic SCC
  • Lesion amenable to CO2 TLM resection.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckVoice DisordersLaryngeal Neoplasms

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOtorhinolaryngologic NeoplasmsRespiratory Tract Neoplasms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 25, 2020

Study Start

August 13, 2013

Primary Completion

August 13, 2018

Study Completion

August 13, 2018

Last Updated

August 25, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share