Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy

NCT02900911 | Completed

• 1 other identifier: 2014/5707/l
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Head and Neck

Keywords

head and neck cancer; dysphagia; rehabilitation; radiation therapy

Outcome Measures

Primary Outcomes (2)

• 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

  2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy

• Change in quality of life at three months post radiotherapy

  Head \& Neck Cancer 35 (HN35)

  2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

Secondary Outcomes (2)

• Change in dysphagia security signs at three months post radiotherapy

  2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

• Change in lingual Force at three months post radiotherapy

  2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

Study Arms (2)

Early rehabilitation

EXPERIMENTAL

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

Other: Early rehabilitation

Later rehabilitation

ACTIVE COMPARATOR

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

Other: Late rehabilitation

Interventions

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.

Early rehabilitation

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

Later rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced head and neck cancer receiving radiotherapy

You may not qualify if:

• Candidates to surgical treatment
• Previous head and neck cancer
• Dysphagia due to causes other than cancer
• Previous head or neck radiation therapy.

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Asociación Española contra el Cáncer: collaborator

Study Sites (1)

Hospital de l'Esperança

Barcelona, 08024, Spain

Location

Related Publications (19)

• 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.

  PMID: 10722011 BACKGROUND

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• 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.

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• 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.

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  PMID: 21136031 BACKGROUND

• 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.

  PMID: 21430531 BACKGROUND

• 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.

  PMID: 20091057 BACKGROUND

• 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.

  PMID: 22508621 BACKGROUND

• 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.

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• 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.

  PMID: 22542950 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 23562564 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: September 14, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

ES (1)