This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.
PRIMARY OBJECTIVES: I. To determine the feasibility and safety of manual therapy for treatment of fibrosis-related dysphagia in head and neck cancer survivors. SECONDARY OBJECTIVES: I.To estimate effect size, dose-response (number of treatment sessions to normalized cervical range of motion), and durability of manual therapy for improving cervical range of motion in head and neck cancer survivors with fibrosis-related late dysphagia. II. To examine functional outcomes after manual therapy in head and neck cancer survivors with fibrosis-related late effects and their association with change in dysphagia grade, cervical extension, and other cofactors. OUTLINE: Participants receive 10 manual therapy sessions performed by a speech pathologist during weeks 1-6. After completion of 6 weeks of therapy, participants perform manual therapy at home daily for 6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
24
Receive manual therapy
M D Anderson Cancer Center
Houston, Texas, United States
Feasibility
Will be determined by completion rate. Completion rate will be defined by completion of the 6 week clinical manual therapy (MT) program without withdrawing and attending a minimum of 2 sessions and the post-treatment assessment. Session attendance will be monitored separately to assess adherence and fidelity. Will summarize fidelity and adherence to the standard MT protocol using quantitative and qualitative methods.
Time frame: Up to 12 weeks
Incidence of adverse events
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events will be tabulated and will be monitored by the trial Data Safety Monitoring Board.
Time frame: Up to 12 weeks
Efficacy and durability of response
Will be determined by cervical range of motion (CROM). CROM for each anatomic plane measured by goniometer.
Time frame: Up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)
Swallowing function and physiology
Measured by videofluoroscopy using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) and Computational Analysis of Swallowing Mechanics (CASM).
Time frame: Baseline to 6 weeks (after manual therapy)
Lingual and jaw range of motion (ROM)
Measured by Therabite ruler.
Time frame: Up to 12 weeks
Swallowing-related quality of life
Measured by the MD Anderson Dysphagia Inventory (MDADI).
Time frame: Up to 12 weeks
Symptom burden
Measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN).
Time frame: Up to 12 weeks
Lymphedema/fibrosis staging
Measured by the Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale.
Time frame: Up to 12 weeks
Performance status
Measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN).
Time frame: Up to 12 weeks
Soft tissue fibrosis
Measured by magnetic resonance imaging.
Time frame: Up to 12 weeks
Improvement in tongue innervation on Electromyography (EMG) findings
Electromyography (EMG) scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'
Time frame: Baseline to 6 weeks (after manual therapy)
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