A Study of Tongue Strength and Endurance Using the Iowa Oral Performance Instrument (IOPI) Tongue Strength Trainer in People With Oral Tongue Cance
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
1 other identifier
interventional
60
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2025
CompletedFirst Submitted
Initial submission to the registry
August 8, 2025
CompletedFirst Posted
Study publicly available on registry
August 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 7, 2028
August 15, 2025
August 1, 2025
3 years
August 8, 2025
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tongue strength as measured by Iowa Oral Performance Instrument/IOPI
Define normative ranges in tongue strength using the Iowa Oral Performance Instrument/IOPI in patients with oral tongue cancers undergoing primary surgical resection.
Up to 6 months
Endurance as measured by Iowa Oral Performance Instrument/IOPI
Define normative ranges in tongue endurance using the Iowa Oral Performance Instrument/IOPI in patients with oral tongue cancers undergoing primary surgical resection.
Up to 6 months
Study Arms (2)
Treatment Group
EXPERIMENTALStandard of care plus intervention with the Iowa Oral Performance Instrument /IOPI. Randomization will be stratified by partial glossectomy versus hemiglossectomy.
Control Group
NO INTERVENTIONParticipants will receive standard of care. Randomization will be stratified by partial glossectomy versus hemiglossectomy.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥18 years old
- Scheduled to undergo primary surgery for oral tongue cancer (glossectomy types 1 to 3) using any type of closure or reconstruction
You may not qualify if:
- Previous radiation therapy to the oral cavity or head and neck
- Previous surgery for oral cavity cancer
- Recurrent oral cavity cancer
- Surgical requirement of extension to involve bone (mandible resection)
- Subtotal or total glossectomy
- Feeding tube dependance prior to surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920, United States
Memoral Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, 11725, United States
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise Cunningham
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2025
First Posted
August 15, 2025
Study Start
August 7, 2025
Primary Completion (Estimated)
August 7, 2028
Study Completion (Estimated)
August 7, 2028
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
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.