TerminatedNot Applicable

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

Stopped: Slower than anticipated enrollment.

United States22 participantsStarted 2020-09-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years
✓. A previous diagnosis of oropharyngeal carcinoma requiring treatment with radiation therapy
✓. Diagnosis/evidence of lymphedema stage 1a or higher by clinical presentation based upon MD Anderson Cancer Center Head and Neck Lymphedema rating scale
✓. EAT-10 score \>4 at Baseline and Randomization Visits (prior to randomizing subject)
✓. The head and neck garments must fit appropriately (for patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy)
✓. Ability to perform swallow exercises
✓. Willing and able to comply with the study protocol requirements and all study-related visit requirements
✓. Willing and able to provide informed consent prior to study participation

Exclusion criteria

✕. Synchronous treatment for cancer (may or may not have successfully complete prior cancer treatment)
✕. Other known causes of dysphagia such as previous radiation to the head and neck, or neuromuscular or neurodegenerative known to have a strong association with dysphagia (i.e., Parkinsons, ALS, MS, OPMD)
✕. Poorly controlled: kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism or parathyroidism, cyclic edema, or Munchausen Syndrome (for which endocrinologist recommends against neck compression)

What they're measuring

Swallow outcomes via modified barium swallow - Penetration-Aspiration Scale (PAS)

Timeframe: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

Swallow outcomes via modified barium swallow - Pharyngeal Constriction Ratio (PCR)

Timeframe: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

Swallow outcomes via modified barium swallow - Upper Esophageal Sphincter Opening (UESmax)

Timeframe: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

Swallow outcomes via modified barium swallow - Esophageal Bolus Transit Time (ETT)

Timeframe: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

Swallow outcomes via modified barium swallow - Normalized residue ratio scale (NRRS)

Timeframe: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

Swallow outcomes via modified barium swallow - Posterior Pharyngeal Wall Thickness (PPW)

Timeframe: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

Trial details

NCT IDNCT04335981

SponsorTactile Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-01

View on ClinicalTrials.gov More Head and Neck Lymphedema trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years
✓. A previous diagnosis of oropharyngeal carcinoma requiring treatment with radiation therapy
✓. Diagnosis/evidence of lymphedema stage 1a or higher by clinical presentation based upon MD Anderson Cancer Center Head and Neck Lymphedema rating scale
✓. EAT-10 score \>4 at Baseline and Randomization Visits (prior to randomizing subject)
✓. The head and neck garments must fit appropriately (for patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy)
✓. Ability to perform swallow exercises
✓. Willing and able to comply with the study protocol requirements and all study-related visit requirements
✓. Willing and able to provide informed consent prior to study participation

Exclusion criteria

✕. Synchronous treatment for cancer (may or may not have successfully complete prior cancer treatment)
✕. Other known causes of dysphagia such as previous radiation to the head and neck, or neuromuscular or neurodegenerative known to have a strong association with dysphagia (i.e., Parkinsons, ALS, MS, OPMD)
✕. Poorly controlled: kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism or parathyroidism, cyclic edema, or Munchausen Syndrome (for which endocrinologist recommends against neck compression)