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

Tactile Medical2 个研究点分布在 1 个国家目标入组 22 人开始时间: 2020年9月24日最近更新: 2022年11月17日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方: Tactile Medical
入组人数: 22
试验地点: 2
主要终点: Swallow outcomes via modified barium swallow - Pharyngeal Constriction Ratio (PCR)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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)
•Carotid sinus hypersensitivity syndrome
•Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
•Symptomatic bradycardia in the absence of a pacemaker
•Internal jugular venous thrombosis (within 3 months)
•Increased intracranial pressure or other contraindications to internal or external jugular venous compression
•Acute radiation dermatitis, unhealed surgical scar, unhealed or open wounds, surgical flap less than 6-8 weeks post-operative
•Facial or head and neck dermal metastasis
•Acute infection/inflammatory disease of the head and neck region (e.g., facial infection, parotid gland abscess, acute cellulitis, or other uncontrolled skin/untreated head and neck inflammatory skin disease)
•Any condition in which increased venous and lymphatic return is undesirable
•Heart failure (acute pulmonary edema, decompensated acute heart failure)
•Subject is pregnant or trying to become pregnant
•Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
•The subject has comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 1½ months
•Any subject who is considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
•The subject has participated in any investigational drug or device research study within 30 days of enrollment