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

Not Applicable

Terminated

• Conditions: Head and Neck Cancer; Stage II Oropharyngeal Cancer; Stage I Hypopharyngeal Cancer; Stage I Laryngeal Cancer; Stage I Oropharyngeal Cancer; Stage III Laryngeal Cancer; Stage IV Hypopharyngeal Cancer; Stage IV Laryngeal Cancer; Stage IV Oropharyngeal Cancer; Stage II Hypopharyngeal Cancer
• Interventions: Behavioral: exercise intervention; Other: questionnaire administration; Procedure: quality-of-life assessment

• Registration Number: NCT01053546
• Lead Sponsor: Wake Forest University Health Sciences

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 Description

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 Timeline

• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Study Start: 2010-11
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (Early exercise group)	exercise intervention	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)	questionnaire administration	Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
Arm I (Early exercise group)	questionnaire administration	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 I (Early exercise group)	quality-of-life assessment	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)	exercise intervention	Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
Arm II (Late exercise group)	quality-of-life assessment	Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.

Primary Outcome Measures

Name	Time	Method
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score	Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Penetration Aspiration Scale (PAS) as assessed via FEES	Baseline and at 1, 3, and 6 months following completion of radiotherapy
Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES	Baseline and at 1, 3, and 6 months following completion of radiotherapy
Lingual strength as assessed by lingual manometry	Baseline and at 1, 3, and 6 months following completion of radiotherapy
Eating Assessment Tool (EAT) quality of life score	Baseline and at 1, 3, and 6 months following completion of radiotherapy
Percent weight recovery	Baseline and at 1, 3, and 6 months following completion of radiotherapy
Percent weight loss	Baseline and at 1, 3, and 6 months following completion of radiotherapy
Feeding tube duration (days)	Baseline and at 1, 3, and 6 months following completion of radiotherapy

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States