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

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.

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Key information

Conditions

Tongue Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases Tongue Diseases Tongue Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering at Basking Ridge (Consent only), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iowa Oral Performance Instrument (IOPI)

Device

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 outcomes

Tongue strength as measured by Iowa Oral Performance Instrument/IOPI

Time frame: Up to 6 months

Define normative ranges in tongue strength using the Iowa Oral Performance Instrument/IOPI in patients with oral tongue cancers undergoing primary surgical resection.
Endurance as measured by Iowa Oral Performance Instrument/IOPI

Time frame: Up to 6 months

Define normative ranges in tongue endurance using the Iowa Oral Performance Instrument/IOPI in patients with oral tongue cancers undergoing primary surgical resection.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Cracchiolo, MD

CONTACT

[email protected]

212-639-8420

Louise Cunningham

CONTACT

[email protected]

212-639-5856

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Aug 15, 2025
Registry last updated: Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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