Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy

Study Overview
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Brief Summary
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Head and neck cancer has a negative impact in swallowing function and quality of life. Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies suggest that interventions should be initiated prior to RT sessions. This study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The study pretends to establish a preventive rehabilitative program with the target of reducing RT side effects and improve patients' quality of life.

Detailed Description
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Head and neck cancer has a negative impact in swallowing function and quality of life. Although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients. Some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (RT), regardless the need of concomitant chemotherapy (RT-QT). Other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction. Patients receiving RT or RT-QT refer worsening of their quality of life, especially during the first days after treatment. One study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. However, this observation should be contrasted with a randomized study.

Official Title
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Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial

Conditions
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Cancer of Head and Neck

Intervention / Treatment
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* Other: Early rehabilitation
* Other: Late rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced head and neck cancer receiving radiotherapy Exclusion Criteria: Candidates to surgical treatment Previous head and neck cancer Dysphagia due to causes other than cancer Previous head or neck radiation therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early rehabilitation<br>Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months | Other: Early rehabilitation<br>* Early swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting 2 weeks before radiotherapy Expiratory/Inspiratory training: the training load is the maximum inspiratory/expiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), three times a day. All sessions will be conducted under the supervision of an expert physiotherapist/swallowing therapist. The total duration of the training program is 6 months.<br>|
| Active Comparator: Later rehabilitation<br>Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy | Other: Late rehabilitation<br>* Late swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting after completing radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dysphagia severity at three months post radiotherapy | 8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and >6, aspiration | 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy | 
| Change in quality of life at three months post radiotherapy | Head & Neck Cancer 35 (HN35) | 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dysphagia security signs at three months post radiotherapy | Security signs (tone of voice, coughing during or after eating, or desaturation of more than 3% compared to baseline pulse oximetry) assessed with the Volume Viscosity Swallow Test | 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy | 
| Change in lingual Force at three months post radiotherapy | Lingual Force: maximum isometric tongue pressure of three peak isometric tongue pressure scores assessed with the IOPI system. | 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, dysphagia, rehabilitation, radiation therapy