Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07124520

Conditions

Tongue Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Iowa Oral Performance Instrument (IOPI)

Study Details

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.

Conditions

Tongue Cancer

Study ID

NCT07124520

Start date

Aug 7, 2025

Status verified date

Jun, 2026

Completion date

Aug 7, 2028

Anticipated

Primary completion date

Aug 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Standard of care plus intervention with the Iowa Oral Performance Instrument /IOPI. Randomization will be stratified by partial glossectomy versus hemiglossectomy.

no intervention: Control Group

Participants will receive standard of care. Randomization will be stratified by partial glossectomy versus hemiglossectomy.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Louise Cunningham

212-639-5856cunningl@mskcc.org

Jennifer Cracchiolo, MD

212-639-8420cracchij@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Consent only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Louise Cunningham

212-639-5856

Memoral Sloan Kettering Monmouth (Consent only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Louise Cunningham

212-639-5856

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Louise Cunningham

212-639-5856

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)

Recruiting

Commack, New York, United States, 11725

Contacts

Louise Cunningham

212-639-5856

Memoral Sloan Kettering Westchester (Consent only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Louise Cunningham

212-639-5856

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Louise Cunningham

212-639-5856

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Louise Cunningham

212-639-5856

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-30.