NCT04335981

Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression

A Randomized, Single-Center Study to Determine Swallow Outcomes in Subjects With Head and Neck Lymphedema Receiving Early Intervention With Pneumatic Compression

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Tactile Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to assess the effect early pneumatic compression (prior to confirming cancer-free status via PET or CT imaging) has on swallow outcomes, positron emission tomography (PET) measurements, function, and complication rate post-radiotherapy in subjects treated for oropharyngeal cancer.

Detailed description

This is a single-center, prospective, randomized, two-arm, wait-list control study that plans to enroll a total of 24 subjects in the United States. A baseline screening will take place where all subjects who provide consent and meet the eligibility criteria following completion of radiotherapy will begin a 6 weeks regimen of in-home swallow exercises. They will then return to the clinic for final screening and randomization into one of two treatment groups: Flexitouch Plus Cellular Connectivity (FT-CC) and Swallow Exercises (Intervention) or Swallow Exercises alone (Standard Care). A total of 3 in-clinic visits and 1 phone call will be conducted over a 12-week period. The Standard Care group will be offered an optional 6 week follow-up period to use the device in-home and will be seen in the clinic for one additional follow-up Visit 2. A reading center with personnel blinded to treatment assignment will be used to interpret the MBS and PET study results.

Conditions

• Head and Neck Lymphedema

Interventions

Type	Name	Description
DEVICE	FT-CC and Swallow Exercises	Once daily treatment with FT Plus with investigational connectivity software and standard of care swallow exercises.
OTHER	Swallow Exercises	Standard of care swallow exercises.

Timeline

• Start date: 2020-09-24
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2020-04-07
• Last updated: 2022-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study