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Completed

NCT Number: NCT02900911

Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy

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.

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Key information

Conditions

Cancer of Head and Neck Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de l'Esperança

Barcelona, 08024, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early rehabilitation

Other

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.

Late Rehabilitation

Other

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

Primary outcomes

  1. Change in dysphagia severity at three months post radiotherapy

    Time frame: 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy

    8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and >6, aspiration

  2. Change in quality of life at three months post radiotherapy

    Time frame: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

    Head & Neck Cancer 35 (HN35)

Secondary outcomes

  1. Change in dysphagia security signs at three months post radiotherapy

    Time frame: 2 weeks before beginning radiotherapy and 3 months after completing 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. Change in lingual Force at three months post radiotherapy

    Time frame: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

    Lingual Force: maximum isometric tongue pressure of three peak isometric tongue pressure scores assessed with the IOPI system.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Asociación Española contra el Cáncer

Registry information

Official study title

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

Acronym: ReDyOR

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2016
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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