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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Wake Forest University Health Sciences

Dates:
Date Received: January 20, 2010
Date Started: November 2010
Date Completion:
Last Updated: February 20, 2017
Last Verified: February 2017