ISRCTN48569216
Completed
未知
A feasibility randomised controlled trial of pre-treatment gastrostomy tube versus oral feeding plus as-needed nasogastric tube feeding in patients undergoing chemoradiation for head and neck cancer
ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)0 sites60 target enrollmentJune 12, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27965848 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29650060
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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