Neoplasms

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Participants will be trained to initiate swallowing during expiration.

Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).

Participants will complete 6 respiratory-swallow phase training sessions that will last approximately one hour.

Respiratory-Swallow Phase Training

Participants will complete 6 "swallow practice" sessions that will last approximately one hour.

Swallow Practice

Bonnie Martin-Harris, PhD

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.

Participants and outcome assessors will be naive to experimental condition.

Training Swallowing Initiation During Expiration

Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer

Evaluates the impact of dysphagia on the quality of life of patients with head and neck cancer

Determines percent (frequency) of the target (expiratory phase) for each swallow.

Measures presence, depth and reaction to penetration and aspiration.

Quantifies pharyngeal space residue obtained in the lateral view during Modified Barium Swallow Study (MBSS)

Measures physiologic swallowing impairment from observations of MBSS recordings

Northwestern Memorial Hospital

Northwestern University

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Laryngeal Diseases

Quality of Life

Patients will undergo active swallowing therapy with a speech and language therapist (twice a week) combined to a detailed program of swallowing auto-exercises (twice a day) from start of radiotherapy to one month after the end.

Swallowing therapy

Franck JEGOUX

Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program.

The main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.

The study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).

Patients in both groups will receive dietary and postural advice from the treating physician. Patients in the experimental group will be treated with an early active swallowing therapy including a consultation with a speech and language therapist twice a week and a detailed program of swallowing auto-exercises twice a day, from the start to one month after the end of radiotherapy. All speech therapists will be given precise guidelines based on the current state of the art and knowledge. All patients will be analyzed in intent-to-treat.

Two ancillary studies will complete this global concept of the evaluation and prediction of severe alteration of Quality of Life (QoL) and Dysphagia.

1. A first study will evaluate videoradioscopy. Its objectives are to evaluate the ability of videoradioscopy at 3 months to predict poor QoL at 6 and 12 months, to identify videoradioscopic predictors of severe dysphagia, asymptomatic aspirations, cricopharyngeal stenoses and active swallowing rehabilitation efficiency. Each patient of both arms of the main study will undergo a videoradioscopy before the beginning of the radiation delivery (baseline evaluation), and at 3 and at 12 months. Data analysis will be centralized and will concern: APS (Aspiration and Penetration Scale) score, residue, Defective Laryngeal elevation, pharyngoesophageal sphincter dysfunction. Data will be correlated to the parameters of the main study in order to establish predictive models.
2. A second ancillary study will evaluate the dose-volume histograms of radiotherapy. The objectives are to identify predictors of dysphagia and of active swallowing rehabilitation efficiency, and to establish "2D" and "3D" predictive models of dysphagia. Imaging and dosimetric data (IMRT (Intensity Modified RadioTherapy) planning) and dose-volume histogram will be collected from the patients of the main clinical trial. Analysis will be centralized. Data will be correlated to the parameters of the main study in order to establish predictive models.

Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer

HNSW = Head and Neck Swallowing Questionnaire

EORTC QLQ = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire

EORTC H\&N = European Organisation for Research and Treatment of Cancer Head and Neck questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Training Swallowing Initiation During Expiration	NCT05278039	Head and Neck C... Dysphagia Oropharyngeal D... Oropharynx Squa...	Respiratory-Swa... Swallow Practic...	18 Years -	Northwestern University
Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer	NCT02892487	Cancer of Head ...	Swallowing ther...	18 Years -	Rennes University Hospital
Training Swallowing Initiation During Expiration	NCT05278039	Head and Neck C... Dysphagia Oropharyngeal D... Oropharynx Squa...	Respiratory-Swa... Swallow Practic...	18 Years -	Northwestern University
Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer	NCT02892487	Cancer of Head ...	Swallowing ther...	18 Years -	Rennes University Hospital
Training Swallowing Initiation During Expiration	NCT05278039	Head and Neck C... Dysphagia Oropharyngeal D... Oropharynx Squa...	Respiratory-Swa... Swallow Practic...	18 Years -	Northwestern University

Spots Global Cancer Trial Database for swallowing rehabilitation