Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07124520
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Tongue Strength and Endurance Using the Iowa Oral Performance Instrument (IOPI) Tongue Strength Trainer in People With Oral Tongue Cance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014062', 'term': 'Tongue Neoplasms'}], 'ancestors': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014060', 'term': 'Tongue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-08-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tongue strength as measured by Iowa Oral Performance Instrument/IOPI', 'timeFrame': 'Up to 6 months', 'description': 'Define normative ranges in tongue strength using the Iowa Oral Performance Instrument/IOPI in patients with oral tongue cancers undergoing primary surgical resection.'}, {'measure': 'Endurance as measured by Iowa Oral Performance Instrument/IOPI', 'timeFrame': 'Up to 6 months', 'description': 'Define normative ranges in tongue endurance using the Iowa Oral Performance Instrument/IOPI in patients with oral tongue cancers undergoing primary surgical resection.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Tongue Cancer', 'Oral Tongue Cancer', 'IOPI Lingual Strength Trainer', 'Iowa Oral Performance Instrument', 'Iowa Oral Performance Instrument Tongue Strength Trainer', 'Memorial Sloan Kettering Cancer Center', '25-162'], 'conditions': ['Tongue Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn more about tongue strength and endurance by using the Iowa Oral Performance Instrument (IOPI). The IOPI is a device that measures tongue pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old\n* Scheduled to undergo primary surgery for oral tongue cancer (glossectomy types 1 to 3) using any type of closure or reconstruction\n\nExclusion Criteria:\n\n* Previous radiation therapy to the oral cavity or head and neck\n* Previous surgery for oral cavity cancer\n* Recurrent oral cavity cancer\n* Surgical requirement of extension to involve bone (mandible resection)\n* Subtotal or total glossectomy\n* Feeding tube dependance prior to surgery'}, 'identificationModule': {'nctId': 'NCT07124520', 'briefTitle': 'A Study of Tongue Strength and Endurance Using the Iowa Oral Performance Instrument (IOPI) Tongue Strength Trainer in People With Oral Tongue Cance', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Normative Ranges of Lingual Strength and Endurance and the Impact of the IOPI Lingual Strength Trainer on Quantitative Functional Outcomes and Patient-Reported Outcomes After Partial Glossectomy or Hemiglossectomy for Oral Tongue Cancer, A Pilot Study', 'orgStudyIdInfo': {'id': '25-162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Standard of care plus intervention with the Iowa Oral Performance Instrument /IOPI. Randomization will be stratified by partial glossectomy versus hemiglossectomy.', 'interventionNames': ['Device: Iowa Oral Performance Instrument (IOPI)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will receive standard of care. Randomization will be stratified by partial glossectomy versus hemiglossectomy.'}], 'interventions': [{'name': 'Iowa Oral Performance Instrument (IOPI)', 'type': 'DEVICE', 'description': 'The Iowa Oral Performance Instrument/IOPI is an instrument that objectively measures tongue strength using a standard-sized air-filled bulb. An individual presses the bulb against the roof of the mouth with the tongue to generate a pressure measurement in kilopascals (kPa). Maximum tongue strength can be determined using a measure of pressure.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louise Cunningham', 'role': 'CONTACT', 'phone': '212-639-5856'}], 'facility': 'Memorial Sloan Kettering at Basking Ridge (Consent only)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louise Cunningham', 'role': 'CONTACT', 'phone': '212-639-5856'}], 'facility': 'Memoral Sloan Kettering Monmouth (Consent only)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louise Cunningham', 'role': 'CONTACT', 'phone': '212-639-5856'}], 'facility': 'Memorial Sloan Kettering Bergen (Consent Only)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louise Cunningham', 'role': 'CONTACT', 'phone': '212-639-5856'}], 'facility': 'Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louise Cunningham', 'role': 'CONTACT', 'phone': '212-639-5856'}], 'facility': 'Memoral Sloan Kettering Westchester (Consent only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louise Cunningham', 'role': 'CONTACT', 'phone': '212-639-5856'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activites)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louise Cunningham', 'role': 'CONTACT', 'phone': '212-639-5856'}], 'facility': 'Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'centralContacts': [{'name': 'Louise Cunningham', 'role': 'CONTACT', 'email': 'cunningl@mskcc.org', 'phone': '212-639-5856'}, {'name': 'Jennifer Cracchiolo, MD', 'role': 'CONTACT', 'email': 'cracchij@mskcc.org', 'phone': '212-639-8420'}], 'overallOfficials': [{'name': 'Louise Cunningham', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}