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 (Actual): 26
• Phase: Not Applicable

Contacts and Locations

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 Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors	To determine feasibility of Manual Therapy (MT). Participants successfully completing the full 6 weeks of MT therapy.	6 weeks of MT
Safety of Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors	To determine safety of Manual Therapy (MT). Participants who did not experience any adverse event while on study.	6 weeks of MT

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.
• McMillan H, Warneke CL, Buoy S, Porsche C, Savage K, Lai SY, Fuller CD, Hutcheson KA. Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The MANTLE Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Apr 1;151(4):319-327. doi: 10.1001/jamaoto.2024.5157.
• McMillan H, Okoro C, Buoy S, Woodman K, Anderson N, Fuller C, Lai SY, Hutcheson K. Hypoglossal Neuropathy in the Pathogenesis of Fibrosis-Related Late-Radiation Associated Dysphagia: A Correlative Analysis Utilizing Electromyography to Explore the Frequency of Clinical and Subclinical Neuropathy in a Pilot Dysphagia Trial. Head Neck. 2026 Feb;48(2):438-448. doi: 10.1002/hed.70024. Epub 2025 Sep 10.

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Actual): July 15, 2022
• Study Completion (Estimated): December 31, 2028

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 (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pathological Conditions, Signs and Symptoms; Fibrosis; Deglutition Disorders; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations
• 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