CompletedPhase 2

Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

39 participantsStarted 2013-08-13

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Voice Outcome

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

Voice Outcome

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

Voice Outcome

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

Voice Outcome

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

Voice Outcome

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

Voice Outcome

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

Trial details

NCT IDNCT04525066

SponsorAyhman Al Afif

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-08-13

View on ClinicalTrials.gov More Head and Neck Neoplasms trials

Plain-language summary

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Voice Outcome

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

Voice Outcome

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

Voice Outcome

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

Voice Outcome

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

Voice Outcome

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

Voice Outcome

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