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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:
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

January 20, 2010
February 27, 2013
November 2010
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01053546 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • 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
    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 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.
    Interventions:
    • Behavioral: exercise intervention
    • Other: questionnaire administration
    • Procedure: 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.
    Interventions:
    • Behavioral: exercise intervention
    • Other: questionnaire administration
    • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
156
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01053546
CCCWFU 98109, NCI-2009-01445
Yes
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
Not Provided
Principal Investigator: Susan Butler Wake Forest School of Medicine
Comprehensive Cancer Center of Wake Forest University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP