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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fibrosis; Dysphagia; Cancer Survivor; Head and Neck Carcinoma
• Intervention / Treatment: Procedure: Manual Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Hutcheson; Phone Number: 713-792-6920; Email: karnold@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (manual therapy); 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; Receive manual therapy; Other Names: MT

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Katherine A Hutcheson, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Hutcheson K, McMillan H, Warneke C, Porsche C, Savage K, Buoy S, Wang J, Woodman K, Lai S, Fuller C. Manual Therapy for Fibrosis-Related Late Effect Dysphagia in head and neck cancer survivors: the pilot MANTLE trial. BMJ Open. 2021 Aug 4;11(8):e047830. doi: 10.1136/bmjopen-2020-047830.

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Fibrosis; Head and Neck Neoplasms; Deglutition Disorders
• Other Study ID Numbers: 2018-0052 (Other Identifier: M D Anderson Cancer Center); NCI-2018-01511 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21CA226200 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No