Dysphagia Clinical Trial
Official title:
The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Adelstein DJ, Saxton JP, Lavertu P, Rybicki LA, Esclamado RM, Wood BG, Strome M, Carroll MA. Maximizing local control and organ preservation in stage IV squamous cell head and neck cancer With hyperfractionated radiation and concurrent chemotherapy. J Clin Oncol. 2002 Mar 1;20(5):1405-10. — View Citation
Bleier BS, Levine MS, Mick R, Rubesin SE, Sack SZ, McKinney K, Mirza N. Dysphagia after chemoradiation: analysis by modified barium swallow. Ann Otol Rhinol Laryngol. 2007 Nov;116(11):837-41. — View Citation
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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. — View Citation
Eisbruch A, Lyden T, Bradford CR, Dawson LA, Haxer MJ, Miller AE, Teknos TN, Chepeha DB, Hogikyan ND, Terrell JE, Wolf GT. Objective assessment of swallowing dysfunction and aspiration after radiation concurrent with chemotherapy for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):23-8. — View Citation
El-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. — View Citation
Hutcheson KA, Barringer DA, Rosenthal DI, May AH, Roberts DB, Lewin JS. Swallowing outcomes after radiotherapy for laryngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2008 Feb;134(2):178-83. doi: 10.1001/archoto.2007.33. — View Citation
Kotz T, Abraham S, Beitler JJ, Wadler S, Smith RV. Pharyngeal transport dysfunction consequent to an organ-sparing protocol. Arch Otolaryngol Head Neck Surg. 1999 Apr;125(4):410-3. — View Citation
Kotz T, Costello R, Li Y, Posner MR. Swallowing dysfunction after chemoradiation for advanced squamous cell carcinoma of the head and neck. Head Neck. 2004 Apr;26(4):365-72. — View 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): — View Citation
Kramer 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. — View 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. — View Citation
Lazarus C, Logemann JA, Gibbons P. Effects of maneuvers on swallowing function in a dysphagic oral cancer patient. Head Neck. 1993 Sep-Oct;15(5):419-24. — View Citation
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Lazarus CL, Logemann JA, Pauloski BR, Colangelo LA, Kahrilas PJ, Mittal BB, Pierce M. Swallowing disorders in head and neck cancer patients treated with radiotherapy and adjuvant chemotherapy. Laryngoscope. 1996 Sep;106(9 Pt 1):1157-66. — View Citation
Lazarus CL, Logemann JA, Pauloski BR, Rademaker AW, Larson CR, Mittal BB, Pierce M. Swallowing and tongue function following treatment for oral and oropharyngeal cancer. J Speech Lang Hear Res. 2000 Aug;43(4):1011-23. — View Citation
Lee 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. — View Citation
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Murry T, Madasu R, Martin A, Robbins KT. Acute and chronic changes in swallowing and quality of life following intraarterial chemoradiation for organ preservation in patients with advanced head and neck cancer. Head Neck. 1998 Jan;20(1):31-7. — View Citation
Newman LA, Vieira F, Schwiezer V, Samant S, Murry T, Woodson G, Kumar P, Robbins KT. Eating and weight changes following chemoradiation therapy for advanced head and neck cancer. Arch Otolaryngol Head Neck Surg. 1998 May;124(5):589-92. — View Citation
Pauloski BR, Logemann JA. Impact of tongue base and posterior pharyngeal wall biomechanics on pharyngeal clearance in irradiated postsurgical oral and oropharyngeal cancer patients. Head Neck. 2000 Mar;22(2):120-31. — View Citation
Pignon JP, Bourhis J, Domenge C, Designé 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. — View Citation
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Smith RV, Kotz T, Beitler JJ, Wadler S. Long-term swallowing problems after organ preservation therapy with concomitant radiation therapy and intravenous hydroxyurea: initial results. Arch Otolaryngol Head Neck Surg. 2000 Mar;126(3):384-9. — View Citation
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N). | This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment. | This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N). | This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment. | This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N). | This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment. | This will be completed at 3 months post treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N). | This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment. | This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N). | This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment. | This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N). | This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment. | This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Functional Oral Intake Scale (FOIS) | A seven point scale of diet tolerance. | This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Functional Oral Intake Scale (FOIS) | A seven point scale of diet tolerance. | This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Functional Oral Intake Scale (FOIS) | A seven point scale of diet tolerance. | This will be completed at 3 post treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Functional Oral Intake Scale (FOIS) | A seven point scale of diet tolerance. | This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Functional Oral Intake Scale (FOIS) | A seven point scale of diet tolerance. | This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment. | No |
Primary | Functional Oral Intake Scale (FOIS) | A seven point scale of diet tolerance. | This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment. | No |
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