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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
No
Susan Butler
Principal Investigator
Wake Forest University
United States: Institutional Review Board
CCCWFU 98109
NCT01053546
November 2010
March 2012
Name | Location |
---|---|
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |