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Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053546
First Posted: January 21, 2010
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose

RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy.

PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise therapy in treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.


Condition Intervention
Head and Neck Cancer Stage I Hypopharyngeal Cancer Stage I Laryngeal Cancer Stage I Oropharyngeal Cancer Stage II Hypopharyngeal Cancer Stage II Laryngeal Cancer Stage II Oropharyngeal Cancer Stage III Hypopharyngeal Cancer Stage III Laryngeal Cancer Stage III Oropharyngeal Cancer Stage IV Hypopharyngeal Cancer Stage IV Laryngeal Cancer Stage IV Oropharyngeal Cancer Behavioral: exercise intervention Other: questionnaire administration Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score [ Time Frame: Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy ]

Secondary Outcome Measures:
  • Penetration Aspiration Scale (PAS) as assessed via FEES [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ]
  • Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ]
  • Feeding tube duration (days) [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ]
  • Eating Assessment Tool (EAT) quality of life score [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ]
  • Lingual strength as assessed by lingual manometry [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ]
  • Percent weight loss [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ]
  • Percent weight recovery [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ]

Enrollment: 14
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (Early exercise group)
Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
Behavioral: exercise intervention
The early exercise group will start study exercises approximately two weeks prior to the onset of XRT. The late exercise group will start study exercises one month after the completion of XRT. Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments.
Other: questionnaire administration
Ancillary study
Procedure: quality-of-life assessment
Ancillary study
Other Name: quality of life assessment
Experimental: Arm II (Late exercise group)
Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
Behavioral: exercise intervention
The early exercise group will start study exercises approximately two weeks prior to the onset of XRT. The late exercise group will start study exercises one month after the completion of XRT. Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments.
Other: questionnaire administration
Ancillary study
Procedure: quality-of-life assessment
Ancillary study
Other Name: quality of life assessment

Detailed Description:

PRIMARY OBJECTIVE:

I. To assess the difference between early and late onset swallowing exercises on swallowing quality of life in patients undergoing chemo/radiation therapy for head and neck cancer.

SECONDARY OBJECTIVE:

I. To assess the difference between early and late onset swallowing exercises on swallowing function in patients undergoing radiation therapy for head and neck cancer.

TERTIARY OBJECTIVE:

I. To assess the difference between early and late onset swallowing exercises on: individual domains of swallowing quality of life; Penetration Aspiration Scale (PAS) as assessed via FEES; diet level (Dysphagia Outcome and Severity Scale (DOSS) as assessed via FEES; feeding tube duration (days); Eating Assessment Tool (EAT); lingual strength as assessed via lingual manometry; and percent weight loss and percent weight recovery.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I (Early exercise group): Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.

Arm II (Late exercise group): Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.

In both arms, swallowing exercises are performed twice daily, 6 days a week, for 12 months following completion of radiotherapy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Written informed consent must be obtained from all participants prior to beginning therapy (participants should have the ability to understand be willing to sign a written informed consent document)
  • Individuals with oropharyngeal, hypopharyngeal, or laryngeal cancer of Stages I-IV undergoing radiation and chemo therapies at Wake Forest Baptist Medical Center
  • Participants will have surgically received no more than selective neck dissection and tumor biopsy (participants who have undergone primary tumor resection or radical neck dissection will not be eligible)
  • Participants must have completed a minimum of third grade education in order to answer questions of the quality of life survey
  • Participants must be willing to participate in the swallowing exercise program

Exclusion

  • Medical history of cerebrovascular accident, Parkinson's disease, any type of dementia, myasthenia gravis, or amyotrophic lateral sclerosis
  • Previous radiation treatment for head/neck cancer
  • Swallowing problem of etiology other than current lesion
  • Pregnant women are not anticipated in the patient population, but would be excluded from participation in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053546


Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Susan Butler Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01053546     History of Changes
Other Study ID Numbers: CCCWFU 98109
NCI-2009-01445 ( Other Identifier: CTRP )
First Submitted: January 20, 2010
First Posted: January 21, 2010
Last Update Posted: May 30, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Hypopharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms