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

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01053546
First received: January 20, 2010
Last updated: February 27, 2013
Last verified: February 2013
  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 Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 Comprehensive Cancer Center of Wake Forest University:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Feeding tube duration (days) [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ] [ Designated as safety issue: No ]
  • Eating Assessment Tool (EAT) quality of life score [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ] [ Designated as safety issue: No ]
  • Lingual strength as assessed by lingual manometry [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ] [ Designated as safety issue: No ]
  • Percent weight loss [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ] [ Designated as safety issue: No ]
  • Percent weight recovery [ Time Frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053546

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

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01053546     History of Changes
Other Study ID Numbers: CCCWFU 98109, NCI-2009-01445
Study First Received: January 20, 2010
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014