Tongue strength and endurance testing with the IOPI in people with oral tongue cancer
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
This will test tongue strength and endurance using a small device called the IOPI in adults scheduled for primary surgery for oral tongue cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT07124520 on ClinicalTrials.gov |
What this trial studies
Participants will have tongue pressure and endurance measured with the Iowa Oral Performance Instrument (IOPI) by trained staff at clinical visits related to their planned primary glossectomy (types 1–3). The protocol enrolls adults who have not had prior radiation or surgery to the oral cavity and who are not feeding-tube dependent. Patients with recurrent disease, required bone resection, or subtotal/total glossectomy are excluded. Data collected will be used to better characterize lingual strength and endurance around surgical treatment.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for primary surgery for oral tongue cancer (glossectomy types 1–3) who have not had prior head and neck radiation or prior oral cavity surgery and are not feeding-tube dependent.
Not a fit: Patients with prior radiation to the head and neck, prior oral cavity surgery, recurrent disease, required mandible resection, subtotal or total glossectomy, or preoperative feeding-tube dependence are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the measurements could help clinicians better understand and track tongue function, which may guide rehabilitation to improve speech and swallowing outcomes.
How similar studies have performed: Previous research has used the IOPI to reliably measure tongue pressure in head and neck and swallowing populations, but its direct impact on long-term clinical outcomes remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering at Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States (Recruiting)
- Memoral Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only) — Commack, New York, United States (Recruiting)
- Memoral Sloan Kettering Westchester (Consent only) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Louise Cunningham — Memorial Sloan Kettering Cancer Center
- Study coordinator: Louise Cunningham
- Email: cunningl@mskcc.org
- Phone: 212-639-5856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.