Iowa Oral Performance Instrument for Tongue Cancer

Recruiting at 6 trial locations

Overseen By Jennifer Cracchiolo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Radiation therapy, Previous surgery, Recurrent cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about tongue strength and endurance in people with tongue cancer. Researchers will use the Iowa Oral Performance Instrument (IOPI) Tongue Strength Trainer to measure tongue strength. Participants will be divided into two groups: one will receive standard care plus use the IOPI, while the other will receive standard care only. Individuals scheduled for their first surgery for oral tongue cancer, without previous treatments in the head or neck area, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Iowa Oral Performance Instrument is safe for measuring tongue strength?

Research shows that the Iowa Oral Performance Instrument (IOPI) is a safe and reliable tool for measuring tongue strength. Studies have demonstrated that the IOPI measures tongue pressure without causing harm. For example, a review found that the IOPI provides consistent results when assessing tongue strength and endurance. Additionally, research with patients who have head and neck cancer showed improvements in tongue strength without major side effects.

Overall, the IOPI is well-tolerated, and these studies have not linked it to any serious negative effects. This suggests that using the IOPI for tongue strength training is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Iowa Oral Performance Instrument (IOPI) for tongue cancer because it offers a novel approach to rehabilitation. Unlike standard care, which may focus on surgical or medication-based interventions, the IOPI targets muscle strength directly by training the tongue muscles. This method could enhance recovery of tongue function post-surgery, potentially improving speech and swallowing abilities more effectively than current options. By stratifying treatment based on the type of glossectomy, this approach also allows for personalized therapy, which could lead to better outcomes for patients.

What evidence suggests that the Iowa Oral Performance Instrument is effective for tongue cancer?

Research has shown that the Iowa Oral Performance Instrument (IOPI) can strengthen the tongue and increase its endurance. In this trial, participants in the treatment group will receive standard care plus intervention with the IOPI. Studies have found that individuals achieved higher maximum tongue pressure (MIP) after training with the IOPI, indicating increased tongue strength. Another study demonstrated that those who used the IOPI as part of an oral rehabilitation program improved their mouth movement. These findings suggest that the IOPI can be a useful tool for enhancing tongue function, particularly for individuals who have undergone surgery for tongue cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Louise Cunningham

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with oral tongue cancer. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements on who can participate.

Inclusion Criteria

I am scheduled for surgery to remove part of my tongue due to cancer.

I am 18 years old or older.

Exclusion Criteria

I have had radiation therapy to my mouth or neck.

My oral cavity cancer has come back.

My surgery will include removing part of my jawbone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care plus intervention with the Iowa Oral Performance Instrument (IOPI) or standard of care alone

Up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Iowa Oral Performance Instrument (IOPI) Tongue Strength Trainer

Trial Overview The study focuses on measuring tongue strength and endurance in people with oral tongue cancer using a device called the Iowa Oral Performance Instrument (IOPI), which gauges tongue pressure.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. iopimedical.com iopimedical.com/studies/

IOPI-Related Studies The experimental group showed a significant increase in tongue muscle strength and thickness, as well as an increase in the mylohyoid and digastric muscle ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07124520

A Study of Tongue Strength and Endurance Using the Iowa ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9496474/

Quantitative Measurement of Swallowing Performance Using ... Among the intervention studies, MIP values were higher after treatment than before, with a better outcome after the experimental tongue training ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/joor.14043

Long‐Term Effects of an Oral Rehabilitation Programme on ... The oral rehabilitation programme was effective in improving the oral DDK rate after a 6-month intervention for patients with tongue cancer, ...

5. pubs.asha.org pubs.asha.org/doi/abs/10.1044/jslhr.4304.1011

Swallowing and Tongue Function Following Treatment for ... This study examined tongue function and its relation to swallowing in 13 subjects with oral or oropharyngeal cancer treated with primary radiotherapy ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1991790220301276

Comparison of the Iowa Oral Performance Instrument and ... This study investigated the correlation between the maximum tongue pressure data measured by the IOPI and the JMS tongue pressure measurement device in young ...