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

Dysphagia Clinical Trial

— MANTLE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03612531
• Other study ID #: 2018-0052
• Secondary ID: NCI-2018-0151120
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor
• Deglutition Disorders
• Dysphagia
• Fibrosis
• Head and Neck Carcinoma
• Head and Neck Neoplasms

Intervention

Procedure:
• Manual Therapy
Receive manual therapy

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	Lingual and jaw range of motion (ROM)	Measured by Therabite ruler.	Up to 12 weeks
Secondary	Swallowing-related quality of life	Measured by the MD Anderson Dysphagia Inventory (MDADI).	Up to 12 weeks
Secondary	Symptom burden	Measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN).	Up to 12 weeks
Secondary	Lymphedema/fibrosis staging	Measured by the Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale.	Up to 12 weeks
Secondary	Performance status	Measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN).	Up to 12 weeks
Secondary	Soft tissue fibrosis	Measured by magnetic resonance imaging.	Up to 12 weeks
Secondary	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)

External Links

•   MD Anderson Cancer Center Website