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

Wake Forest University (WFU)

Status: Terminated

Conditions: Stage IV Oropharyngeal Cancer; Stage II Hypopharyngeal Cancer; Stage I Hypopharyngeal Cancer; Stage I Laryngeal Cancer; Stage IV Hypopharyngeal Cancer; Stage II Oropharyngeal Cancer; Stage III Hypopharyngeal Cancer; Head and Neck Cancer; Stage III Oropharyngeal Cancer; Stage II Laryngeal Cancer; Stage IV Laryngeal Cancer; Stage III Laryngeal Cancer; Stage I Oropharyngeal Cancer

Treatments: Behavioral: exercise intervention; Other: questionnaire administration; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01053546

IRB00010437

CCCWFU 98109 (Other Identifier)

NCI-2009-01445 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Arm I (Early exercise group)

Experimental group

Description:

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.

Treatment:

Other: questionnaire administration

Procedure: quality-of-life assessment

Behavioral: exercise intervention

Arm II (Late exercise group)

Experimental group

Description:

Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.

Treatment:

Other: questionnaire administration

Procedure: quality-of-life assessment

Behavioral: exercise intervention