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Despite the considerable use of oral steroids in the regular management of benign vocal fold lesions there is little evidence base in the literature. This study will investigate the efficacy of oral steroids for the treatment of vocal fold lesions in a controlled manner. The specific aim of this study is to determine the effectiveness of of a short course of oral steroids prior to behavioral voice therapy in patients with benign, phonotraumatic vocal fold lesions. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.
The study will investigate the potential added advantage of the use of steroids in patients undergoing voice therapy. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The measurements that will be collected in all these phases are the Voice Handicap Index (VHI)-10 , the noise to harmonic ratio H/N, the fundamental frequency Fo, The transglottic airflow and subglottic pressure. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid | Active Comparator | Prednizone pills. 4 day course 2 x 20mg per day. |
|
| Placebo | Placebo Comparator | Lactose Pills. 4 day course 2 x 20mg per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid | Drug | A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months | Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable. | pre-treatment/baseline to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lesion Size From Baseline to 2 Months | Still images of the glottis will be obtained from the video such that the vocal folds are captured in an open position (at least 40 degrees at the anterior commissure). Image J software (NIH) will then be used to outline the lesion and measure the length of the ipsilateral vocal fold. | pre-treatment/baseline to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milan Amin, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Steroid | Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy. |
| FG001 | Placebo | Lactose Pills. 4 day course 2 x 20mg per day. Lactose Pills: 4 day course 2 x 20mg per da |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 6 patients were lost to follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Steroid | Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months | Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable. | Posted | Mean | Standard Deviation | score on a scale | pre-treatment/baseline to 2 months |
|
2 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Steroid | Prednizone pills. 4 day course 2 x 20mg per day. Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Milan Amin | NYU Langone Health | 646-754-1206 | Milan.Amin@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2013 | Feb 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D013256 | Steroids |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Lactose Pills | Dietary Supplement | 4 day course 2 x 20mg per da |
|
| Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months. | A change in VHI scores from pre-treatment to following treatment. Scores can range from 0-120: 0-30: Mild Minimal amount of handicap 31-60: Moderate Often seen in patients with vocal nodules, polyps, or cysts 60-120: Severe Often seen | Pre-treatment/baseline to following treatment/2 months |
| Number of Participants That Showed Improved (Lower) Average Decibels (db) Output. | 2 months |
Lactose Pills. 4 day course 2 x 20mg per day.
Lactose Pills: 4 day course 2 x 20mg per da
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Change in Lesion Size From Baseline to 2 Months | Still images of the glottis will be obtained from the video such that the vocal folds are captured in an open position (at least 40 degrees at the anterior commissure). Image J software (NIH) will then be used to outline the lesion and measure the length of the ipsilateral vocal fold. | Posted | Mean | Standard Deviation | mm | pre-treatment/baseline to 2 months |
|
|
|
| Secondary | Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months. | A change in VHI scores from pre-treatment to following treatment. Scores can range from 0-120: 0-30: Mild Minimal amount of handicap 31-60: Moderate Often seen in patients with vocal nodules, polyps, or cysts 60-120: Severe Often seen | Posted | Mean | Full Range | score on a scale | Pre-treatment/baseline to following treatment/2 months |
|
|
|
| Secondary | Number of Participants That Showed Improved (Lower) Average Decibels (db) Output. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Placebo | Lactose Pills. 4 day course 2 x 20mg per day. Lactose Pills: 4 day course 2 x 20mg per da | 0 | 14 | 0 | 14 | 0 | 14 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |