Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma
NCT ID: NCT04525066
Last Updated: 2020-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2013-08-13
2018-08-13
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Group - Receiving Hyaluronic Acid Injection
Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
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.
Control Group - Not Receiving Hyaluronic Acid Injection
Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older with a biopsy-proven T1a, T1b or T2 glottic SCC
* Lesion amenable to CO2 TLM resection.
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Nova Scotia Health Authority
OTHER
Ayhman Al Afif
OTHER
Responsible Party
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Ayhman Al Afif
Principal Investigator
Other Identifiers
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1020322
Identifier Type: -
Identifier Source: org_study_id
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