Clinical trial · Interventional
Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy
Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early rehabilitation | Other | — | UNRESOLVED |
| Late rehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early rehabilitation
- description
- Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months
- interventionNames
- Other: Early rehabilitation
- type
- ACTIVE_COMPARATOR
- label
- Later rehabilitation
- description
- Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy
- interventionNames
- Other: Late rehabilitation
Primary outcomes (2)
- measure
- Change in dysphagia severity at three months post radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (19)
- BACKGROUNDStenson 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
- BACKGROUNDQuer 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. PMID 11526864
- BACKGROUNDKulbersh 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. PMID 16735913
- BACKGROUNDCarroll 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. PMID 17989581
- BACKGROUNDLazarus 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. PMID 19337126
- BACKGROUNDDirix 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. PMID 19553033
- BACKGROUNDMurphy 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.