NCT03612531: MANTLE

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

Active, enrolled NA Last updated 14 October 2025

What this trial tests

NA trial testing Manual Therapy in Cancer Survivor in 24 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 August 2018

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	24
Start date	6 August 2018
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across United States

Drugs / interventions tested

• Manual Therapy

Conditions studied

• Cancer Survivor — all drugs for Cancer Survivor →
• Dysphagia — all drugs for Dysphagia →
• Fibrosis — all drugs for Fibrosis →
• Head and Neck Carcinoma — all drugs for Head and Neck Carcinoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Cancer Survivor or Dysphagia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Manual Therapy for Fibrosis-Related Late Effect Dysphagia in head and neck cancer survivors: the pilot MANTLE trial.
   Hutcheson K, McMillan H, Warneke C, Porsche C, et al · · 2021 · cited 18× · PMID 34348950 · DOI 10.1136/bmjopen-2020-047830
2. Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The MANTLE Nonrandomized Clinical Trial.
   McMillan H, Warneke CL, Buoy S, Porsche C, et al · · 2025 · cited 6× · PMID 39913160 · DOI 10.1001/jamaoto.2024.5157
3. Exploring Quantitative MRI Biomarkers of Head and Neck Post-Radiation Lymphedema and Fibrosis: Post Hoc Analysis of a Prospective Trial.
   MD Anderson Head and Neck Cancer Symptom Working Group, Mao S, Wang J, McMillan H, et al · · 2025 · cited 5× · PMID 39794912 · DOI 10.1002/hed.28062
4. 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.
   McMillan H, Okoro C, Buoy S, Woodman K, et al · · 2026 · cited 1× · PMID 40927950 · DOI 10.1002/hed.70024
5. Individual patient-reported symptom items discriminate imaging-graded dysphagia in head and neck cancer patients treated with radiotherapy: secondary analysis of pooled prospective studies.
   Manduchi B, Jefferson TC, Moreno AC, Barbon CEA, et al · · 2026 · PMID 41506576 · DOI 10.1016/j.radonc.2026.111365
6. Exploring quantitative MRI biomarkers of head and neck post-radiation lymphedema and fibrosis: Post hoc analysis of a prospective trial
   MD Anderson Head and Neck Cancer Symptom Working Group, Mao S, Wang J, McMillan H, et al · · 2024 · DOI 10.1101/2024.06.30.24309685
7. Letter to the editor referencing "Body composition changes in patients with head and neck cancer under active treatment: a scoping review".
   Cacicedo J, Mendizabal N, Arietaleanizbeaskoa MS. · · 2022 · PMID 33742245 · DOI 10.1007/s00520-021-05999-z