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NCT Number: NCT03612531

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Therapy

Procedure

Receive manual therapy

Other names: MT

Primary outcomes

  1. Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors

    Time frame: 6 weeks of MT

    To determine feasibility of Manual Therapy (MT). Participants successfully completing the full 6 weeks of MT therapy.

  2. Safety of Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors

    Time frame: 6 weeks of MT

    To determine safety of Manual Therapy (MT). Participants who did not experience any adverse event while on study.

Secondary outcomes

  1. Efficacy and Durability of Response

    Time frame: Up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks)

    Will be determined by cervical range of motion (CROM). CROM for each anatomic plane measured by goniometer.

  2. Swallowing Function and Physiology

    Time frame: Baseline to 6 weeks (after manual therapy)

    Measured by videofluoroscopy using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) and Computational Analysis of Swallowing Mechanics (CASM).

  3. Lingual and Jaw Range of Motion (ROM)

    Time frame: Up to 12 weeks

    Measured by Therabite ruler.

  4. Swallowing-related Quality of Life

    Time frame: Up to 12 weeks

    Measured by the MD Anderson Dysphagia Inventory (MDADI).

  5. Symptom Burden

    Time frame: Up to 12 weeks

    Measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN).

  6. Lymphedema/Fibrosis Staging

    Time frame: Up to 12 weeks

    Measured by the Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale.

  7. Performance Status

    Time frame: Up to 12 weeks

    Measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN).

  8. Soft Tissue Fibrosis

    Time frame: Up to 12 weeks

    Measured by magnetic resonance imaging.

  9. Improvement in Tongue Innervation on Electromyography (EMG) Findings

    Time frame: Baseline to 6 weeks (after manual therapy)

    Electromyography (EMG) scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: MANTLE

Important dates

Study start
2018
Primary completion
2022
Study completion
2028
First posted
Aug 2, 2018
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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