ClinicalTrials.gg
RecruitingNCT07124520Updated Jun 30, 2026

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

An interventional study of Iowa Oral Performance Instrument (IOPI) in Tongue Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 73 studies in Tongue Neoplasms with a site in United States — 8 open to participants now, 11 under way, 2 of them phase 3. Tongue Neoplasms · United States.

Planned enrollment
22nd of 61
60 · median 43
Started
2025
with 3 others
No phase
13 of 73
5 open now
Primary completion
2028-08
later than 8 of 10 live
Registered
71st of 73
by date
Lead sponsor
4 of 73
Memorial Sloan Kettering Cancer Center

Among the 73 studies in Tongue Neoplasms with a site in United States, this one is the 22nd largest by planned enrollment of the 61 interventional ones that give a count, is one of 4 that started in 2025, is one of 13 with no phase, reaches primary completion later than 8 of the 10 other live ones, and was the 71st registered.

Tongue Neoplasms

121 studies on the registry are indexed under Tongue Neoplasms; 12 are open to participants now.

Browse Tongue Neoplasms studies →

Open to participants now

8 of the 73 studies in Tongue Neoplasms with a site in United States are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 11 Tongue Neoplasms studies recruiting now, 9 (82%) set no upper age limit and 1 (9%) stops at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 73 studies in Tongue Neoplasms with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Tongue Cancer

Browse trials for

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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study 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.

    Device: Iowa Oral Performance Instrument (IOPI)

  • No intervention
    Control Group

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

Interventions

  • DeviceIowa 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 6 months

  2. 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.

    Time frame: Up to 6 months

07

Study locations

7 of 7 sites recruiting
  • Memorial Sloan Kettering at Basking Ridge (Consent only)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Louise Cunningham · Contact212-639-5856
  • Memoral Sloan Kettering Monmouth (Consent only)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Louise Cunningham · Contact212-639-5856
  • Memorial Sloan Kettering Bergen (Consent Only)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Louise Cunningham · Contact212-639-5856
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
    Commack, New York 11725, United States
    Recruiting
    • Louise Cunningham · Contact212-639-5856
  • Memoral Sloan Kettering Westchester (Consent only)
    Harrison, New York 10604, United States
    Recruiting
    • Louise Cunningham · Contact212-639-5856
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
    New York, New York 10065, United States
    Recruiting
    • Louise Cunningham · Contact212-639-5856
  • Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
    Uniondale, New York 11553, United States
    Recruiting
    • Louise Cunningham · Contact212-639-5856
08

References and documents

Individual participant data

Plan to share: Yes — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2025 (actual). Primary completion is estimated for Aug 2028, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2025
First posted
Aug 15, 2025
StartActual
Aug 7, 2025
Primary completionEst.
Aug 7, 2028
CompletionEst.
Aug 7, 2028
Last update
Jun 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07124520
Responsible party
Sponsor
First posted
Aug 15, 2025
Start date
Aug 7, 2025
Primary completion
Aug 7, 2028 (estimated)
Completion
Aug 7, 2028 (estimated)
Last update
Jun 30, 2026

Study contacts

Louise Cunningham
Contact
cunningl@mskcc.org
212-639-5856
Jennifer Cracchiolo, MD
Contact
cracchij@mskcc.org
212-639-8420
Louise Cunningham
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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