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
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Head and Neck||Other: Early rehabilitation Other: Late rehabilitation||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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
- 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)
- 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
- 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.
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
|Contact: Palmira Foro, PhDfirstname.lastname@example.org|
|Contact: Anna Guillen, PhDemail@example.com|
|Hospital de l'Esperança||Recruiting|
|Barcelona, Spain, 08024|
|Contact: Anna Guillen, PhD 0034933674214 firstname.lastname@example.org|