Topic: Cancer, Ear, nose and throat, Gastroenterology
Conditions
Interventions
Study participants will be randomised to one of two treatment arms in a 1:1 ratio:
1. Pre-CRT (chemo-radiation treatment) gastrostomy arm
G-tube insertion will take pl
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with stage III and IV HNSCC who are suitable for primary CRT with curative intent. This can include patients having induction chemotherapy prior to CRT. All patients would have been investigated and diagnosed as above by the respective cancer MDT. Main inclusion criteria are as follows: 1. Grade 1 pre-treatment dysphagia, as defined by Common Terminology Criteria for Adverse Events v4.0 (defined as: asymptomatic/symptomatic/able to eat regular diet) 2. Consent to be randomised 3. Adult patients
Exclusion criteria
Exclusion criteria: Patients who: 1. Decline to participate 2. Are unable to give informed consent 3. Cannot receive a gastrostomy for medical reasons 4. Do not receive treatment with curative intent 5. Have malnutrition requiring immediate initiation of enteral feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assess willingness to randomise (by qualitative interviews with clinicians) and be randomised (by review of patient screening logs) 2. Assess retention and drop-out rates | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assess compliance and refine interventions and study processes 2. Estimate parameters to inform definitive trial design 3. Assess value of information based on modelling exercise 4. Assess incidence of reported adverse events | — |
Countries
United Kingdom
Outcome results
None listed