Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The Pilot MANTLE Trial

Conditions
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Cancer Survivor, Dysphagia, Fibrosis, Head and Neck Carcinoma

Intervention / Treatment
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* Procedure: Manual Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Late Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade >= 2 dysphagia on Modified Barium Swallow (MBS) >= 2 years after curative-intent radiotherapy for head and neck cancer Grade >= 2 Common Terminology Criteria for Adverse Events (CTCAE) fibrosis Willing and able to return for 10 sessions over 6 weeks of therapy Exclusion Criteria: Active recurrent or second primary head and neck, central nervous system, or thoracic cancer at time of enrollment Active osteoradionecrosis or other non-healing wounds (e.g., fistula, ulcer, soft tissue necrosis) in manual therapy (MT) regions of interest at time of enrollment History of subtotal or total glossectomy or total laryngectomy Functionally limiting cardiac, pulmonary, or neuromuscular disease Current tracheostomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (manual therapy)<br>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. | Procedure: Manual Therapy<br>* Receive manual therapy<br>* Other names: MT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and durability of response | Will be determined by cervical range of motion (CROM). CROM for each anatomic plane measured by goniometer. | 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). | Baseline to 6 weeks (after manual therapy) | 
| Lingual and jaw range of motion (ROM) | Measured by Therabite ruler. | Up to 12 weeks | 
| Swallowing-related quality of life | Measured by the MD Anderson Dysphagia Inventory (MDADI). | Up to 12 weeks | 
| Symptom burden | Measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN). | Up to 12 weeks | 
| Lymphedema/fibrosis staging | Measured by the Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale. | Up to 12 weeks | 
| Performance status | Measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN). | Up to 12 weeks | 
| Soft tissue fibrosis | Measured by magnetic resonance imaging. | 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' | Baseline to 6 weeks (after manual therapy) |