Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-02 @ 12:02 AM
Study NCT ID:
NCT04525066
Status:
COMPLETED
Last Update Posted:
2020-08-25
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-20', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Voice Outcome', 'timeFrame': 'Change at 3 months post-operatively compared to baseline.', 'description': 'Voice Handicap Index-10 Scores'}, {'measure': 'Voice Outcome', 'timeFrame': 'Changes at 12 months post-operatively compared to baseline.', 'description': 'Voice Handicap Index-10 Scores'}, {'measure': 'Voice Outcome', 'timeFrame': 'Changes at 24 months post-operatively compared to baseline.', 'description': 'Voice Handicap Index-10 Scores'}, {'measure': 'Voice Outcome', 'timeFrame': 'Changes at 3 months post-operatively compared to baseline.', 'description': 'Maximum Phonation Time'}, {'measure': 'Voice Outcome', 'timeFrame': 'Changes at 12 months post-operatively compared to baseline.', 'description': 'Maximum Phonation Time'}, {'measure': 'Voice Outcome', 'timeFrame': 'Changes at 24 months post-operatively compared to baseline.', 'description': 'Maximum Phonation Time'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '24 months post-augmentation', 'description': 'Kaplan-Meier Survival Analysis'}, {'measure': 'Disease free survival', 'timeFrame': '24 months post-augmentation', 'description': 'Kaplan-Meier Survival Analysis'}, {'measure': 'Recurrence-free survival', 'timeFrame': '24 months post-augmentation', 'description': 'Kaplan-Meier Survival Analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms', 'Head and Neck Squamous Cell Carcinoma', 'Voice Disorders', 'Laryngeal Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* 18 years of age or older with a biopsy-proven T1a, T1b or T2 glottic SCC\n* Lesion amenable to CO2 TLM resection.\n\nExclusion Criteria:\n\n* Previous radiotherapy to the head and neck.\n* Palpable, or radiographic, pathological lymphadenopathy.\n* Allergy, or sensitivity, to HA or components of the injectable.\n* Neurological disorder affecting phonation, such as multiple sclerosis or stroke.'}, 'identificationModule': {'nctId': 'NCT04525066', 'briefTitle': 'Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Injection Thyroplasty During Transoral Laser Microsurgery for Early Glottic Cancer: Single-blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1020322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group - Receiving Hyaluronic Acid Injection', 'description': 'Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.', 'interventionNames': ['Drug: Hyaluronic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group - Not Receiving Hyaluronic Acid Injection', 'description': 'Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.', 'interventionNames': ['Other: No Hyaluronic Acid Injection Injection']}], 'interventions': [{'name': 'Hyaluronic acid', 'type': 'DRUG', 'otherNames': ['Hyaluronic Acid Laryngoplasty'], 'description': 'Patients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.', 'armGroupLabels': ['Treatment Group - Receiving Hyaluronic Acid Injection']}, {'name': 'No Hyaluronic Acid Injection Injection', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control Group - Not Receiving Hyaluronic Acid Injection']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ayhman Al Afif', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ayhman Al Afif', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}