None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the efficacy of pharyngo-oesophageal dilatation for improving ease and comfort of swallowing in patients with head and neck cancer therapy-induced swallowing difficulty. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with head and neck cancer for which surgery and chemoradiation therapy finished at least 12 months previously, which has caused ongoing difficulty swallowing. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either the dilatation procedures, or to receive a single oeosophageal endoscopy during which no dilatation is provided. Participants in the dilatation group will receive a series of dilatation procedures. These involve passage of dilators to expand the calibre of the oesophagus under sedation and will occur at 2-3 weekly intervals. All participants will be followed up for 2 years following the final procedure to evaluate swallowing symptoms and satisfaction with the treatment. It is hoped that this trial will provide information on whether pharyngo-oesophageal dilatation may be an effective method for reducing symptoms of difficulties swallowing which have been caused by cancer therapies for head and neck cancer patients.
Interventions
Recruited participants are randomised into 2 groups: 1) treatment arm; 2) placebo arm.
All participants will undergo a diagnostic endoscopic examination (standard of practice) using a gastroscope with an outer diameter of 9.2mm (Olympus GIF-H190, Olympus Corp, Tokyo), at Day Surgery St Goerge Hospital. Sedation is administered by anaesthesiologists using fentanyl, midazolam, and propofol.
Participants allocated to the treatment arm will receive a series of endoscopic dilatations at of the ph
Recruited participants are randomised into 2 groups: 1) treatment arm; 2) placebo arm. All participants will undergo a diagnostic endoscopic examination (standard of practice) using a gastroscope with an outer diameter of 9.2mm (Olympus GIF-H190, Olympus Corp, Tokyo), at Day Surgery St Goerge Hospital. Sedation is administered by anaesthesiologists using fentanyl, midazolam, and propofol. Participants allocated to the treatment arm will receive a series of endoscopic dilatations at of the pharyngo-oesophageal junction at the time endoscopy. Endoscopic dilatations are performed using bougie dilators (Savary-Gilliard, Wilson-Cook Medical, Winston-Salem, NC, USA). The selection of initial dilator size is based on an estimated lumen diameter from endoscopic view as determined by experienced gastroenterologist consultants. Dilators are passed sequentially in increments of 1mm diameter with periodic inspection following some or all dilator passages until one or more of the following is reached: 1) mucosal tear identified upon re-inspection, or 2) a maximal dilator diameter of 16mm is passed. Based on our pilot data [Paramsohthy, S et al. Gastroenterology 2012 suppl), a median of 3 dilatations per patient was necessary to achieve an adequate clinical response. Hence, patients are re-scheduled for repeat dilatation at 2 weekly intervals until 1) satisfactory clinical response is achieved on global assessment; or 2) a maximal dilator of 16mm is passed; or 3) further increment in dilator size is considered unsafe. Participants allocated to placebo arm will receive no endoscopic dilatation.
Sponsors
St George & Sutherland Clinical School, University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) self-reported problematic pharyngeal dysphagia 12 months beyond the surgeries and chemoradiation for head and neck cancer; 2) abnormal Sydney Swallow Questionnaire score (above 234).
Exclusion criteria
1) local cancer recurrence; 2) any neurological disorders known to cause pharyngeal dysfunction (e.g. Parkinson's disease, cerebral vascular accident, inflammatory myopathy, motor neuron disease).
Outcome results
None listed