Head and Neck NeoplasmsPhase 2NCT04525066

Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

A Phase 2 study testing Hyaluronic acid and No Hyaluronic Acid Injection Injection in people with Head and Neck Neoplasms and Head and Neck Squamous Cell Carcinoma, run by Ayhman Al Afif.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Voice Disorders
What is being tested?: Hyaluronic acid and No Hyaluronic Acid Injection Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: No sites listed yet
Study dates: 13 Aug 2013to 13 Aug 2018
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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

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.

Conditions: Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Voice Disorders, Laryngeal Cancer
Being tested: Hyaluronic acid, No Hyaluronic Acid Injection Injection
Medical subject headings: Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Voice Disorders, Laryngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyaluronic acidDrug
Also called Hyaluronic Acid Laryngoplasty
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 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.

Study groups in NCT04525066
Study group	Role	What they receive
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. Receives: 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. Receives: Other: No Hyaluronic Acid Injection Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Voice Outcome
Voice Handicap Index-10 Scores
Measured: Change at 3 months post-operatively compared to baseline.
Voice Outcome
Voice Handicap Index-10 Scores
Measured: Changes at 12 months post-operatively compared to baseline.
Voice Outcome
Voice Handicap Index-10 Scores
Measured: Changes at 24 months post-operatively compared to baseline.
Voice Outcome
Maximum Phonation Time
Measured: Changes at 3 months post-operatively compared to baseline.
Voice Outcome
Maximum Phonation Time
Measured: Changes at 12 months post-operatively compared to baseline.
Voice Outcome
Maximum Phonation Time
Measured: Changes at 24 months post-operatively compared to baseline.

Secondary outcomes (3)

Overall survival
Kaplan-Meier Survival Analysis
Measured: 24 months post-augmentation
Disease free survival
Kaplan-Meier Survival Analysis
Measured: 24 months post-augmentation
Recurrence-free survival
Kaplan-Meier Survival Analysis
Measured: 24 months post-augmentation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 201313 Aug 2018

First posted25 Aug 2020
Study start13 Aug 2013
Primary completion13 Aug 2018
Study completion13 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04525066
Sponsor's protocol ID: 1020322
Status last verified: Aug 2020
First submitted: 11 Aug 2020
Last updated: 25 Aug 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

All Head and Neck Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Injection Thyroplasty During Transoral Laser Microsurgery for Early Glottic Cancer: Single-blinded Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04525066
Acronym / sponsor ID: 1020322
Conditions: Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Voice Disorders, Laryngeal Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Ayhman Al AfifUniversity, hospital or other
Collaborators: Nova Scotia Health Authority
Study start: 13 Aug 2013 (actual)
Primary completion: 13 Aug 2018 (actual)
Study completion: 13 Aug 2018 (actual)
First posted: 25 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Treatment Group - Receiving Hyaluronic Acid Injection	Experimental	Drug: Hyaluronic acidRandomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
Control Group - Not Receiving Hyaluronic Acid Injection	Placebo comparator	Other: No Hyaluronic Acid Injection InjectionRandomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hyaluronic acidAlso: Hyaluronic Acid LaryngoplastyPatients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.	Drug	Treatment Group - Receiving Hyaluronic Acid Injection
No Hyaluronic Acid Injection InjectionPatients 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	Control Group - Not Receiving Hyaluronic Acid Injection

Primary outcome

Voice Outcome
Time frame: Change at 3 months post-operatively compared to baseline.
Voice Handicap Index-10 Scores
Voice Outcome
Time frame: Changes at 12 months post-operatively compared to baseline.
Voice Handicap Index-10 Scores
Voice Outcome
Time frame: Changes at 24 months post-operatively compared to baseline.
Voice Handicap Index-10 Scores
Voice Outcome
Time frame: Changes at 3 months post-operatively compared to baseline.
Maximum Phonation Time
Voice Outcome
Time frame: Changes at 12 months post-operatively compared to baseline.
Maximum Phonation Time
Voice Outcome
Time frame: Changes at 24 months post-operatively compared to baseline.
Maximum Phonation Time

3 secondary outcomes

Overall survival
Time frame: 24 months post-augmentation
Disease free survival
Time frame: 24 months post-augmentation
Recurrence-free survival
Time frame: 24 months post-augmentation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
Individual participant dataSharing planned: No

Related trials for Head and Neck Neoplasms

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hyaluronic acid and No Hyaluronic Acid Injection Injection in people with Head and Neck Neoplasms and Head and Neck Squamous Cell Carcinoma, run by Ayhman Al Afif.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Voice Outcome (time frame: Change at 3 months post-operatively compared to baseline.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04525066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.