A Study of Tongue Strength and Endurance Using the Iowa Oral Performance Instrument (IOPI) Tongue Strength Trainer in People With Oral Tongue Cance

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Tongue Cancer

Treatments: Device: Iowa Oral Performance Instrument (IOPI)

Study type: Interventional

Funder types: Other

Identifiers

NCT07124520

25-162

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Treatment Group

Experimental group

Description:

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

Treatment:

Device: Iowa Oral Performance Instrument (IOPI)

Control Group

No Intervention group

Description:

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