Clinical trial · Interventional
The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients
NCT01349309CI-TRIAL-00020069completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to find out if doing prophylactic or preventative swallowing exercises from the start of cancer treatment can improve the ability to swallow when the treatment is completed and beyond.
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 |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Swallowing Exercise Group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Swallowing Exercise Group
- description
- Swallowing Exercise Group: This arm will undergo the protocol that involves intensive swallowing exercises to begin at the start of the cancer treatment. Those patients randomized to the intensive therapy protocol will be required to participate in weekly swallowing therapy sessions either in person or over the phone and perform the learned swallowing exercises three times a day. In addition, these patients will document their swallowing practice on a daily basis.
- interventionNames
- Behavioral: Swallowing Exercise Group
- type
- NO_INTERVENTION
- label
- Control
- description
- Control Arm: This arm will receive the standard of care which provides swallowing evaluation and treatment once symptoms of swallowing dysfunction are experienced by the patient.
Primary outcomes (12)
- measure
- Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Patient diagnosed with head and neck cancer who will be receiving radiation therapy either alone of with chemotherapy as their treatment modality. Exclusion criteria: * Patients with a history of neurologic disease * Patients with previous head and neck cancer or surgical or radiation treatment to the head and neck region * Patients taking medication that might effect their swallowing function * Patients with gastroenterologic dysfunction * Patients who have previously undergone swallowing therapy * Patients with cognitive impairments that limit their ability to follow and comply with multi-step commands
References
Publications (27)
- BACKGROUNDLee NY, de Arruda FF, Puri DR, Wolden SL, Narayana A, Mechalakos J, Venkatraman ES, Kraus D, Shaha A, Shah JP, Pfister DG, Zelefsky MJ. A comparison of intensity-modulated radiation therapy and concomitant boost radiotherapy in the setting of concurrent chemotherapy for locally advanced oropharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):966-74. doi: 10.1016/j.ijrobp.2006.06.040. PMID 17145527
- BACKGROUNDEl-Sayed S, Nelson N. Adjuvant and adjunctive chemotherapy in the management of squamous cell carcinoma of the head and neck region. A meta-analysis of prospective and randomized trials. J Clin Oncol. 1996 Mar;14(3):838-47. doi: 10.1200/JCO.1996.14.3.838. PMID 8622032
- BACKGROUNDPignon JP, Bourhis J, Domenge C, Designe L. Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data. MACH-NC Collaborative Group. Meta-Analysis of Chemotherapy on Head and Neck Cancer. Lancet. 2000 Mar 18;355(9208):949-55. PMID 10768432
- BACKGROUNDMendenhall WM, Amdur RJ, Stringer SP, Villaret DB, Cassisi NJ. Radiation therapy for squamous cell carcinoma of the tonsillar region: a preferred alternative to surgery? J Clin Oncol. 2000 Jun;18(11):2219-25. doi: 10.1200/JCO.2000.18.11.2219. PMID 10829041
- BACKGROUNDKramer S, Gelber RD, Snow JB, Marcial VA, Lowry LD, Davis LW, Chandler R. Combined radiation therapy and surgery in the management of advanced head and neck cancer: final report of study 73-03 of the Radiation Therapy Oncology Group. Head Neck Surg. 1987 Sep-Oct;10(1):19-30. doi: 10.1002/hed.2890100105. PMID 3449477
- BACKGROUNDRobbins KT. Barriers to winning the battle with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):4-5. doi: 10.1016/s0360-3016(02)02713-x. No abstract available. PMID 12007934
- Calais G, Alfonsi M, Bardet E, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Oudinot P, Bertrand P. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999 Dec 15;91(24):2081-6. doi: 10.1093/jnci/91.24.2081.