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| Name | Class |
|---|---|
| Northwestern Memorial Hospital | OTHER |
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Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.
Head and neck cancers (HNC) have increased to epidemic levels in the United States. Despite good response to cancer treatment, survivors are suffering life-long toxicities that result in swallowing problems (dysphagia). Treatment options for dysphagia after HNC are extremely limited, focus on swallowing movements alone, and do not consider the importance of respiratory-swallow phase patterning. Prior evidence has demonstrated that when aberrant respiratory-swallow phase patterning is present (initiation of swallowing during inspiration) in patients with HNC, there is a higher occurrence of swallowing impairments, increased residue, and airway invasion. Further, it has been well established that the expiratory limb of the respiratory cycle provides a biomechanically advantageous set point in which to initiate safe and efficient swallowing. This randomized, controlled, Phase II clinical trial examines if respiratory-swallow phase training improves airway protection and swallowing efficiency in HNC survivors who are three or more months post-completion of first-line cancer treatment. The primary goal (Aim 1) is to determine if respiratory-swallow phase training results in increased frequency (%) of swallows initiated during expiration and improved swallowing safety. The secondary goal (Aim 2) is to examine the impact of respiratory-swallow phase training on the frequency of swallows initiated during expiration in wakeful, naturalistic swallowing environments, including eating and drinking. The investigators will recruit 88 HNC survivors with dysphagia, impaired respiratory-swallow phase patterning, and airway compromise. The investigators will deliver therapy remotely using a telehealth platform and an innovative wearable sensor that provides real-time visual feedback of respiratory-swallow movements. Endpoints will be measured from synchronized videofluoroscopic and respiratory-swallow sensor recordings at baseline, within 1-week post-treatment, and 1-month and 3-months post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory-Swallow Phase Training | Experimental | Participants will be trained to initiate swallowing during expiration. |
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| Swallow Practice | Sham Comparator | Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory-Swallow Phase Training | Behavioral | Participants will complete 6 respiratory-swallow phase training sessions that will last approximately one hour. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency (%) of swallows initiated during expiration | Determines percent (frequency) of the target (expiratory phase) for each swallow. | Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment. |
| Change in Penetration-Aspiration Scale scores | Measures presence, depth and reaction to penetration and aspiration. | Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 1-8 and higher scores indicate worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Normalized Residue Ratio Scale scores | Quantifies pharyngeal space residue obtained in the lateral view during Modified Barium Swallow Study (MBSS) | Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 0 to 100% and higher scores indicate worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in M.D. Anderson Dysphagia Inventory (MDADI) scores | Evaluates the impact of dysphagia on the quality of life of patients with head and neck cancer | Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 20 to 100 and higher scores indicate worse outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie Martin-Harris, PhD | Northwestern Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| Northwestern University |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D003680 | Deglutition Disorders |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Randomized-controlled trial
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Participants and outcome assessors will be naive to experimental condition.
| Swallow Practice | Other | Participants will complete 6 "swallow practice" sessions that will last approximately one hour. |
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| Change in Modified Barium Swallow Impairment Profile (MBSImP) scores |
Measures physiologic swallowing impairment from observations of MBSS recordings |
| Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Oral Total scores range from 0-22 and Pharyngeal Total scores range from 0-26 and higher values indicate worse outcome. |
| Evanston |
| Illinois |
| 60208 |
| United States |
| D004066 |
| Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |