Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients
Condition: Head & Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for
      how it should be managed. This pilot randomized controlled trial evaluated the relative
      benefit of a battery of isometric / isotonic exercises on the maintenance of muscle
      composition and function for swallowing in Head / Neck Cancer patients undergoing
      chemo-radiation therapy.
    

Detailed description: 
      Swallowing deficits resulting from oropharyngeal cancer and the ablative therapies used to
      control the disease are often devastating to the functional feeding outcome in these
      patients. Most patients will experience some degree of dysphagia along with nutritional
      decline. In particular, the swallowing outcome of those patients treated with external beam
      radiation is suggested to be poorer than those patients treated by surgical interventions
      alone. It has also been postulated that the formation of radiation-induced fibrotic tissue,
      along with the acute radiation effects (edema, mucositis, xerostomia) may act collectively to
      promote muscular disuse or atrophy, and the noted decline in swallowing function. We
      therefore suggest that a program of swallowing exercises may help facilitate and maintain
      muscle function in the oral cavity and pharynx during radiotherapy, thus preserving or
      supporting swallowing function in these patients.

      This study will follow a randomized controlled trial design. Patients with confirmed head /
      neck cancer identified for planned radiotherapy will undergo a baseline evaluation including
      clinical and instrumental swallowing assessment, nutritional examination, and MRI prior to
      CRT. Subjects will then be randomized to one of three intervention arms representing control,
      placebo and intervention groups. Patients will be treated for 6 weeks and progress reassessed
      at 6 months. Outcome assessment will be completed by a blinded observer. Primary outcomes
      include; I)Oropharyngeal active muscle volume, signal intensity, and tissue composition over
      time as identified by T2 weighted MRI, II)Level of functional swallowing ability,III)Patient
      perception of swallowing function and quality of life.The results of the study will provide
      information on the efficacy (or lack of efficacy) of isometric / isotonic exercises for the
      maintenance of swallowing function post radiotherapy for Head /Neck cancer.
    

Intervention name(s): focused attention sessions; Valchuff; Pharyngocise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Patient management by the attending Radiation oncologist "as usual". Patients assigned to this condition received focused attention sessions during the total course of their CRT treatment from a Speech Language Pathologist, consisting of weekly phone calls to monitor their swallowing outcome during the radiotherapy period.; Standardised sham or placebo swallowing therapy comprised a buccal extension maneuver ("valchuff") and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of CRT treatment.; Standardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their CRT treatment (up to a maximum of 6 weeks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Head/ neck cancer; Swallowing; behavioral treatment