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Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy (ReDyOR)

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ClinicalTrials.gov Identifier: NCT02900911
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
Asociación Española contra el Cáncer
Information provided by (Responsible Party):
Esther Marco Navarro, Parc de Salut Mar

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Other: Early rehabilitation Other: Late rehabilitation Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : May 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early rehabilitation
Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months
Other: Early rehabilitation

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.


Active Comparator: Later rehabilitation
Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy
Other: Late rehabilitation
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900911


Contacts
Contact: Palmira Foro, PhD 0034933674383 pforo@parcdesalutmar.cat
Contact: Anna Guillen, PhD 0034933674214 aguillen@parcdesalutmar.cat

Locations
Spain
Hospital de l'Esperança Recruiting
Barcelona, Spain, 08024
Contact: Anna Guillen, PhD    0034933674214    aguillen@parcdesalutmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
Asociación Española contra el Cáncer

Publications:

Responsible Party: Esther Marco Navarro, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02900911     History of Changes
Other Study ID Numbers: 2014/5707/l
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

Keywords provided by Esther Marco Navarro, Parc de Salut Mar:
head and neck cancer
dysphagia
rehabilitation
radiation therapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms