Pre-treatment gastrostomy tube versus oral feeding plus as-needed nasogastric tube feeding in patients undergoing chemoradiation for head and neck cancer

Not Applicable

Completed

• Conditions: Topic: Cancer, Ear, nose and throat, Gastroenterology; Subtopic: Head and Neck Cancer, Ear (all Subtopics), Gastroenterology; Disease: Head and Neck, Ear, nose & throat, All Gastroenterology; Cancer

• Registration Number: ISRCTN48569216
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27965848 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29650060

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-12
• Study Completion: 2016-06-14
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified