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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
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.
Ancillary study
Ancillary study
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
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
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
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