Clinical trial · Interventional
Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors
Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The Pilot MANTLE Trial
NCT03612531CI-TRIAL-00119531MANTLEactive not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivor | — | UNRESOLVED | — |
| Dysphagia | — | UNRESOLVED | — |
| Fibrosis | — | UNRESOLVED | — |
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Manual Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (manual therapy)
- description
- 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.
- interventionNames
- Procedure: Manual Therapy
Primary outcomes (2)
- measure
- Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors
- timeFrame
- 6 weeks of MT
- description
- To determine feasibility of Manual Therapy (MT). Participants successfully completing the full 6 weeks of MT therapy.
- measure
- Safety of Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors
- timeFrame
- 6 weeks of MT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDMcMillan 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. PMID 40927950
- DERIVEDMcMillan 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. PMID 39913160
- DERIVEDHutcheson 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. PMID 34348950