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

ConditionTongue Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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