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

NCT ID: NCT01053546

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-03-31

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.

Conditions

Head and Neck Cancer; Stage I Hypopharyngeal Cancer; Stage I Laryngeal Cancer; Stage I Oropharyngeal Cancer; Stage II Hypopharyngeal Cancer; Stage II Laryngeal 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

exercise intervention

Intervention Type: BEHAVIORAL

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.

questionnaire administration

Intervention Type: OTHER

Ancillary study

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary study

Arm II (Late exercise group)

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

Group Type: EXPERIMENTAL

exercise intervention

Intervention Type: BEHAVIORAL

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.

questionnaire administration

Intervention Type: OTHER

Ancillary study

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary study

Interventions

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.

Intervention Type: BEHAVIORAL

questionnaire administration

Ancillary study

Intervention Type: OTHER

quality-of-life assessment

Ancillary study

Intervention Type: PROCEDURE

Other Intervention Names

quality of life assessment

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Butler

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NCI-2009-01445

Identifier Type: OTHER

Identifier Source: secondary_id

CCCWFU 98109

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00010437

Identifier Type: -

Identifier Source: org_study_id