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Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score

Outcome Time Frame:

Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy

Safety Issue:

No

Principal Investigator

Susan Butler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 98109

NCT ID:

NCT01053546

Start Date:

November 2010

Completion Date:

March 2012

Related Keywords:

  • 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
  • Laryngeal Neoplasms
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms
  • Hypopharyngeal Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157