Recruiting NCT07124520
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, An Unblinded: Randomized Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iowa Oral Performance Instrument (IOPI).
- Who it may be relevant to
- Registry conditions: Tongue Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Iowa Oral Performance Instrument (IOPI)
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.
Primary outcome measures
- Tongue strength as measured by Iowa Oral Performance Instrument/IOPI [Time frame: Up to 6 months]
- Endurance as measured by Iowa Oral Performance Instrument/IOPI [Time frame: Up to 6 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Memorial Sloan Kettering at Basking Ridge (Consent only) — Basking Ridge
- Memoral Sloan Kettering Monmouth (Consent only) — Middletown
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only) — Commack
- Memoral Sloan Kettering Westchester (Consent only) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
- Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) — Uniondale
Identifiers
NCT: NCT07124520 · 25-162