Research

The Hutcheson Laboratory's research focus spans outcome measurement and therapeutic strategies to improve head and neck cancer survivorship. With a large network of interdisciplinary global collaborators, we developed a program of research to measure, predict and improve function for head and neck cancer survivorship — with an emphasis on swallowing and communication. At the heart of this work are patient-centered and provider-informed strategies developed with real-world clinical implementation in mind.

DIGEST™ is an analysis method used to grade the severity of pharyngeal dysphagia based on results of a modified barium swallow (MBS) study or flexible endoscopic evaluation of swallowing (DIGEST-FEES). DIGEST uses a basic flowsheet and rubric to summarize the patterns of penetration/aspiration and pharyngeal residue as markers of swallowing safety and efficiency. The method provides a reproducible way to achieve a summary grading of dysphagia from the MBS or FEES observations (i.e., none, mild, moderate, severe or profound/life threatening pharyngeal dysphagia) that aligns to the NCI’s CTCAE framework for clinician-grading of toxicity in oncology. 

DIGEST was initially developed for videofluoroscopy or MBS in head and neck cancer in 2016. Version 2.

Updates

• Version 2 (for MBS)
• Adaptation of Version 2 for FEES (DIGEST-FEES)
• Mapping DIGEST decision tree to IDDSI
• Translations and validations in new clinical population of DIGEST

Contact

View the DIGEST resource page for online training and more information.

For training, reliability testing, translations and external validations, please contact DIGEST@mdanderson.org.

The Hutcheson Laboratory leads practice changing supportive care clinical trials that seek to improve functional outcomes after head and neck cancer — with a particular emphasis on swallowing and radiotherapy side effects. Our trials span the continuum of survivorship from preventive or proactive therapy strategies to management of late effects of cancer therapy.

Completed

PRO-ACTIVE

PRO-ACTIVE (NCT03455608) is an international multi-site pragmatic randomized clinical trial comparing ideal timing and intensity of delivering swallowing therapy for patients receiving head and neck radiotherapy. PRO-ACTIVE (high and low intensity) and RE-ACTIVE swallowing therapies were compared during radiotherapy.

Related publications:

• PRO-ACTIVE: results of a pragmatic Phase IV randomized trial comparing the effectiveness of PROphylACTic swallow InterVEntion for patients receiving radiotherapy for head and neck cancer
• The PRO-ACTIVE trial protocol: a randomized study comparing the effectiveness of PROphylACTic swallow InterVEntion for patients receiving radiotherapy for head and neck cancer
• Therapy Manuals for Clinically Implementing Proactive and Reactive Swallowing Therapies During Head and Neck Radiotherapy: Using the TIDieR Framework to Disseminate PRO-ACTIVE Trial Interventions
• Exploring the Acceptability of Behavioral Swallowing Interventions for Head and Neck Cancer Patients During Radiotherapy: A Qualitative Study of Patients' Experience
• The Acceptability of Behavioural Swallowing Interventions for Head and Neck Cancer Patients During Radiotherapy: A Qualitative Study Exploring Experiences of Clinical Trial Speech-Language Pathologists
• Exploring patient experiences with a telehealth approach for the PRO-ACTIVE trial intervention in head and neck cancer patients

MANTLE

MANTLE (NCT03612531) is a pilot trial that studied manual therapy as a component of treatment for fibrosis-related late-radiation associated dysphagia. 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 symptoms and range of motion in participants experiencing fibrosis as a side effect of head and neck cancer treatment.

Related publications:

• Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The MANTLE Nonrandomized Clinical Trial
• Exploring Quantitative MRI Biomarkers of Head and Neck Post-Radiation Lymphedema and Fibrosis: Post Hoc Analysis of a Prospective Trial
• 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

ESMT

Expiratory Muscle Strength Training (ESMT) pilot trial (Effects of Expiratory Muscle Strength Training on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy)

Related publications:

• Expiratory muscle strength training for radiation-associated aspiration after head and neck cancer: A case series
• Expiratory muscle strength training evaluated with simultaneous high-resolution manometry and electromyography
• Cough strength and expiratory force in aspirating and nonaspirating postradiation head and neck cancer survivors

PATH

PATH (NCT05036330) is a study to better understand how individuals adopt the ProvoxLife® Heat and Moisture Exchanger (HME) system for pulmonary rehabilitation after total laryngectomy.

Active

STOP

STOP is a Phase I/II dose finding trial examining the side effects and best dose of steroid therapy (prednisone or methylprednisolone) in improving symptoms of late radiation-associated lower cranial neuropathy in head and neck cancer survivors. High dose steroid may help improve symptoms associated with late radiation-associated cranial neuropathy.

Provox® Activalve® RCT

The Provox® Activalve® RCT is a multi-site, international randomized trial examining whether the Provox® Activalve® extends device life in routine users (i.e., not as a “problem solver”). The trial will also examine different replacement strategies for indwelling voice prostheses in individuals who have undergone total laryngectomy. This study compares standard voice prosthesis replacements with routine and prophylactic exchange models of the Provox® Activalve®, an FDA-approved device approved for the indication of premature device failure. The primary objective is to examine expanded indications for use of the Provox® Activalve® to improve device life and optimize quality of life after surgery.

Functional outcomes measurement for oncology clinical trials

We provide longitudinal functional outcome measurement for cooperative group, multi-site trials as well as investigator-initiated trials in the MD Anderson Multidisciplinary Head and Neck Cancer Program. The lab uses a mix of validated patient-reported and clinician-graded measures, with particular emphasis on swallowing related outcomes.

Cooperative group/multi-site trials

• ECOG-3311 (Read about trial results here)
• HN002
• PATHOS
• IMPT/IMRT

OPC-SURVIVOR is a multi-investigator research program co-led by the Hutcheson Lab with legacy support from the Charles and Daneen Stiefel Oropharynx Fund and a program project grant from the National Cancer Institute (NCI). OPC-SURVIVOR focuses on characterizing novel phenotypes, validating non-invasive measures for clinical use and early-phase trials targeting delayed sequelae of oropharyngeal cancers including:

• Mandibular osteoradionecrosis (OPC-ORN)
• Lower cranial neuropathy (OPC-NERVE)
• Late radiation associated dysphagia (OPC-RAD)

From 2014 to 2024, the Hutcheson Lab developed and led the Patient Reported Outcomes/Function (PROF) Core of the MD Anderson Oropharynx Database. Since 2015, the PROF Core prospectively tracks PROs and functional outcomes of patients from baseline through 5+ years’ survival, with particular emphasis on swallowing outcomes.

Longitudinal outcomes include PRO instruments (including MDASI-HN, MDADI, EQ-5D), the modified barium swallow study (including with DIGEST grading) and functional status measures (including PSS-HN, feeding tube). The PROF Core, now led by Dr. Carly Barbon, is an integral component of the OPC-SURVIVOR program, with a one-of-a-kind dataset available to internal and external investigators.

• Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer (NCT01893307)
• Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose) (NCT06912763)
• Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/​Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE) (NCT06494111)
• Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/​or Radiotherapy (LONE-RANGR2) (NCT06167291)
• Prospective, longitudinal digital activity monitoring before and after treatment of low-risk oropharyngeal squamous cell carcinoma: A feasibility study
• Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL stage 2a-2b/Bayesian Phase II trial (NCT03224000)
• A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer (NCT03114462)
• Phase II Randomized Trial of Stereotactic Onco-Ablative Reirradiation versus Conventionally Fractionated Conformal Radiotherapy for Patients with Small Inoperable Head and Neck Tumors (SOAR-HN) (NCT03164460)
• Immuno-Chemotherapy as single treatment modality for Larynx Preservation (ICoLP) (NCT04030455)
• Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma (NCT03799445)