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Clinical Trials/ISRCTN48569216
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

Registry
who.int
Start Date
June 12, 2014
End Date
June 14, 2016
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

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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