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

Primary Purpose

Cancer of Head and Neck

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Early rehabilitation
Late rehabilitation
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer of Head and Neck focused on measuring head and neck cancer, dysphagia, rehabilitation, radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de l'Esperança

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early rehabilitation

Later rehabilitation

Arm Description

Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months

Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy

Outcomes

Primary Outcome Measures

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
Change in quality of life at three months post radiotherapy
Head & Neck Cancer 35 (HN35)

Secondary Outcome Measures

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
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.

Full Information

First Posted
February 15, 2016
Last Updated
September 18, 2020
Sponsor
Parc de Salut Mar
Collaborators
Asociación Española contra el Cáncer
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1. Study Identification

Unique Protocol Identification Number
NCT02900911
Brief Title
Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy
Acronym
ReDyOR
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 Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
Collaborators
Asociación Española contra el Cáncer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head and Neck
Keywords
head and neck cancer, dysphagia, rehabilitation, radiation therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early rehabilitation
Arm Type
Experimental
Arm Description
Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months
Arm Title
Later rehabilitation
Arm Type
Active Comparator
Arm Description
Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy
Intervention Type
Other
Intervention Name(s)
Early rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Late rehabilitation
Intervention Description
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 Measure Information:
Title
Change in dysphagia severity at three months post radiotherapy
Description
8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and >6, aspiration
Time Frame
2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
Title
Change in quality of life at three months post radiotherapy
Description
Head & Neck Cancer 35 (HN35)
Time Frame
2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Secondary Outcome Measure Information:
Title
Change in dysphagia security signs at three months post radiotherapy
Description
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
Time Frame
2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Title
Change in lingual Force at three months post radiotherapy
Description
Lingual Force: maximum isometric tongue pressure of three peak isometric tongue pressure scores assessed with the IOPI system.
Time Frame
2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital de l'Esperança
City
Barcelona
ZIP/Postal Code
08024
Country
Spain

12. IPD Sharing Statement

Citations:
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Citation
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Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy

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