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
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
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
NCT ID
NCT02900911
First Posted
February 15, 2016
Last Updated
September 18, 2020
Sponsor
Parc de Salut Mar
Collaborators
Asociación Española contra el Cáncer
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:
PubMed Identifier
10722011
Citation
Stenson KM, MacCracken E, List M, Haraf DJ, Brockstein B, Weichselbaum R, Vokes EE. Swallowing function in patients with head and neck cancer prior to treatment. Arch Otolaryngol Head Neck Surg. 2000 Mar;126(3):371-7. doi: 10.1001/archotol.126.3.371.
Results Reference
background
PubMed Identifier
11526864
Citation
Quer M, Leon X, Orus C, Recher K, Gras JR. [Analysis of 2,500 squamous cell carcinoma of the head and neck]. Acta Otorrinolaringol Esp. 2001 Apr;52(3):201-5. doi: 10.1016/s0001-6519(01)78198-8. Spanish.
Results Reference
background
PubMed Identifier
16735913
Citation
Kulbersh BD, Rosenthal EL, McGrew BM, Duncan RD, McColloch NL, Carroll WR, Magnuson JS. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006 Jun;116(6):883-6. doi: 10.1097/01.mlg.0000217278.96901.fc.
Results Reference
background
PubMed Identifier
17989581
Citation
Carroll WR, Locher JL, Canon CL, Bohannon IA, McColloch NL, Magnuson JS. Pretreatment swallowing exercises improve swallow function after chemoradiation. Laryngoscope. 2008 Jan;118(1):39-43. doi: 10.1097/MLG.0b013e31815659b0.
Results Reference
background
PubMed Identifier
19337126
Citation
Lazarus CL. Effects of chemoradiotherapy on voice and swallowing. Curr Opin Otolaryngol Head Neck Surg. 2009 Jun;17(3):172-8. doi: 10.1097/MOO.0b013e32832af12f.
Results Reference
background
PubMed Identifier
19553033
Citation
Dirix P, Abbeel S, Vanstraelen B, Hermans R, Nuyts S. Dysphagia after chemoradiotherapy for head-and-neck squamous cell carcinoma: dose-effect relationships for the swallowing structures. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):385-92. doi: 10.1016/j.ijrobp.2008.11.041. Epub 2009 Jun 24.
Results Reference
background
PubMed Identifier
19028344
Citation
Murphy BA, Gilbert J. Dysphagia in head and neck cancer patients treated with radiation: assessment, sequelae, and rehabilitation. Semin Radiat Oncol. 2009 Jan;19(1):35-42. doi: 10.1016/j.semradonc.2008.09.007.
Results Reference
background
PubMed Identifier
19711127
Citation
Platteaux N, Dirix P, Dejaeger E, Nuyts S. Dysphagia in head and neck cancer patients treated with chemoradiotherapy. Dysphagia. 2010 Jun;25(2):139-52. doi: 10.1007/s00455-009-9247-7. Epub 2009 Aug 27.
Results Reference
background
PubMed Identifier
21136031
Citation
Tang Y, Shen Q, Wang Y, Lu K, Wang Y, Peng Y. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus. Strahlenther Onkol. 2011 Jan;187(1):39-44. doi: 10.1007/s00066-010-2151-0. Epub 2010 Dec 10.
Results Reference
background
PubMed Identifier
21430531
Citation
Roe JW, Ashforth KM. Prophylactic swallowing exercises for patients receiving radiotherapy for head and neck cancer. Curr Opin Otolaryngol Head Neck Surg. 2011 Jun;19(3):144-9. doi: 10.1097/MOO.0b013e3283457616.
Results Reference
background
PubMed Identifier
20091057
Citation
Lin PH, Hsiao TY, Chang YC, Ting LL, Chen WS, Chen SC, Wang TG. Effects of functional electrical stimulation on dysphagia caused by radiation therapy in patients with nasopharyngeal carcinoma. Support Care Cancer. 2011 Jan;19(1):91-9. doi: 10.1007/s00520-009-0792-2. Epub 2009 Nov 29.
Results Reference
background
PubMed Identifier
22508621
Citation
Kotz T, Federman AD, Kao J, Milman L, Packer S, Lopez-Prieto C, Forsythe K, Genden EM. Prophylactic swallowing exercises in patients with head and neck cancer undergoing chemoradiation: a randomized trial. Arch Otolaryngol Head Neck Surg. 2012 Apr;138(4):376-82. doi: 10.1001/archoto.2012.187.
Results Reference
background
PubMed Identifier
21739096
Citation
Tedla M, Valach M, Carrau RL, Varga I, Profant M, Mraz P, Weismann P. Impact of radiotherapy on laryngeal intrinsic muscles. Eur Arch Otorhinolaryngol. 2012 Mar;269(3):953-8. doi: 10.1007/s00405-011-1686-8. Epub 2011 Jul 8.
Results Reference
background
PubMed Identifier
22542950
Citation
Russi EG, Corvo R, Merlotti A, Alterio D, Franco P, Pergolizzi S, De Sanctis V, Ruo Redda MG, Ricardi U, Paiar F, Bonomo P, Merlano MC, Zurlo V, Chiesa F, Sanguineti G, Bernier J. Swallowing dysfunction in head and neck cancer patients treated by radiotherapy: review and recommendations of the supportive task group of the Italian Association of Radiation Oncology. Cancer Treat Rev. 2012 Dec;38(8):1033-49. doi: 10.1016/j.ctrv.2012.04.002. Epub 2012 Apr 27.
Results Reference
background
PubMed Identifier
23640737
Citation
Hutcheson KA, Lewin JS, Barringer DA, Lisec A, Gunn GB, Moore MW, Holsinger FC. Late dysphagia after radiotherapy-based treatment of head and neck cancer. Cancer. 2012 Dec 1;118(23):5793-9. doi: 10.1002/cncr.27631. Epub 2012 May 17.
Results Reference
background
PubMed Identifier
24078216
Citation
Wall LR, Ward EC, Cartmill B, Hill AJ. Physiological changes to the swallowing mechanism following (chemo)radiotherapy for head and neck cancer: a systematic review. Dysphagia. 2013 Dec;28(4):481-493. doi: 10.1007/s00455-013-9491-8.
Results Reference
background
PubMed Identifier
23475195
Citation
Citak E, Tulek Z. Longitudinal quality of life in Turkish patients with head and neck cancer undergoing radiotherapy. Support Care Cancer. 2013 Aug;21(8):2171-83. doi: 10.1007/s00520-013-1774-y. Epub 2013 Mar 9.
Results Reference
background
PubMed Identifier
22762238
Citation
Long YB, Wu XP. A randomized controlled trail of combination therapy of neuromuscular electrical stimulation and balloon dilatation in the treatment of radiation-induced dysphagia in nasopharyngeal carcinoma patients. Disabil Rehabil. 2013 Mar;35(6):450-4. doi: 10.3109/09638288.2012.697250. Epub 2012 Jul 4.
Results Reference
background
PubMed Identifier
23562564
Citation
Rathod S, Gupta T, Ghosh-Laskar S, Murthy V, Budrukkar A, Agarwal J. Quality-of-life (QOL) outcomes in patients with head and neck squamous cell carcinoma (HNSCC) treated with intensity-modulated radiation therapy (IMRT) compared to three-dimensional conformal radiotherapy (3D-CRT): evidence from a prospective randomized study. Oral Oncol. 2013 Jun;49(6):634-42. doi: 10.1016/j.oraloncology.2013.02.013. Epub 2013 Apr 4.
Results Reference
background
Learn more about this trial
Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy
We'll reach out to this number within 24 hrs