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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01511 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0052 | Other Identifier | M D Anderson Cancer Center | |
| R21CA226200 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (manual therapy) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Therapy | Procedure | Receive manual therapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine A Hutcheson | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40927950 | Derived | 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. | |
| 39913160 | Derived | 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. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 7, 2026 | |
| Reset | Jun 2, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2026 | Jun 2, 2026 | |||
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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) |
| 34348950 | Derived | 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. |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |