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

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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer; Stage I Laryngeal Cancer; Stage II Laryngeal Cancer; Stage I Hypopharyngeal Cancer; Stage I Oropharyngeal Cancer; Stage II Hypopharyngeal 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
• Intervention / Treatment: Procedure: quality-of-life assessment; Other: questionnaire administration; Behavioral: exercise intervention

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: quality-of-life assessment; Ancillary study; Other Names: quality of life assessment; Other: questionnaire administration; Ancillary study; Behavioral: exercise intervention; 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.
Experimental: Arm II (Late exercise group); Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.	Procedure: quality-of-life assessment; Ancillary study; Other Names: quality of life assessment; Other: questionnaire administration; Ancillary study; Behavioral: exercise intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Feeding tube duration (days)	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
Lingual strength as assessed by lingual manometry	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
Percent weight recovery	Baseline and at 1, 3, and 6 months following completion of radiotherapy

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Susan Butler, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 20, 2010
• First Posted (Estimate): January 21, 2010

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Head and Neck Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms; Hypopharyngeal Neoplasms
• Other Study ID Numbers: IRB00010437; NCI-2009-01445 (Other Identifier: CTRP); CCCWFU 98109 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No