Manual Therapy for Fibrosis-Related Late Effect Dysphagia in head and neck cancer survivors: the pilot MANTLE trial

Katherine Hutcheson, Holly McMillan, Carla Warneke, Christine Porsche, Kiara Savage, Sheila Buoy, Jihong Wang, Karin Woodman, Stephen Lai, Clifton Fuller, Katherine Hutcheson, Holly McMillan, Carla Warneke, Christine Porsche, Kiara Savage, Sheila Buoy, Jihong Wang, Karin Woodman, Stephen Lai, Clifton Fuller

Abstract

Introduction: Late dysphagia that develops or persists years after head and neck cancer (HNC) is a disabling survivorship issue. Fibrosis is thought to stiffen connective tissues and compress peripheral nerve tracts, thereby contributing to diminished strength, flexibility, and in some cases denervation of swallowing muscles. Manual therapy (MT) is used in cancer survivors for pain and other indications, but it is unknown if increasing blood flow, flexibility and cervical range of motion (CROM) in the head and neck may improve late dysphagia.

Methods and analysis: Manual Therapy for Fibrosis-Related Late Effect Dysphagia (MANTLE) is a National Cancer Institute-funded prospective single-arm pilot trial evaluating the feasibility, safety and therapeutic potential of MT in patients with late dysphagia after radiotherapy (RT) for HNC. Disease-free survivors ≥2 years after curative-intent RT for HNC with at least moderate dysphagia and grade ≥2 Common Terminology Criteria for Adverse Events version 4.0 fibrosis are eligible. The target sample size is 24 participants who begin the MANTLE programme. MANTLE is delivered in 10 MT sessions over 6 weeks with an accompanying home exercise programme (HEP). Patients then transition to a 6-week post-washout period during which they complete the HEP and then return for a final post-washout evaluation. Feasibility (primary endpoint) and safety will be examined. Serial assessments include CROM, modified barium swallow studies, quantitative MRI, electromyography (optional) and patient-reported outcomes as secondary, tertiary and exploratory endpoints.

Ethics and dissemination: The research protocol and informed consent document was approved by the Institutional Review Board at the University of Texas MD Anderson Cancer Center. Findings will be disseminated through peer-reviewed publication that will be made publicly available on PubMed Central on acceptance for publication, in compliance with NIH public access policy.

Trial registration number: NCT03612531.

Keywords: head & neck surgery; radiation oncology; speech pathology.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Cervical extension and aspiration improved in case example after manual therapy (MT). Exemplar case before (top) and after (bottom) single session of MT 18 years post-treatment, surgery and radiotherapy for head and neck cancer. Note red arrows on modified barium swallow study depicting residual bolus in pharynx directed anteriorly toward airway with cervical posture in resting forward head drop (top), and directed posteriorly toward oesophagus with cervical extension improved (bottom). While neither swallowing function or nor cervical biomechanics is normalised or ideal, functional gains were observed. CROM, cervical range of motion.
Figure 2
Figure 2
Manual Therapy for Fibrosis-Related Late Effect Dysphagia trial schema. CROM, cervical range of motion; HNC, head and neck cancer; MBS, modified barium swallow; MT, manual therapy; PROs, patient-reported outcomes; RAD, radiation-associated dysphagia; RT, radiotherapy.

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