Protocol for a randomized controlled trial of early prophylactic feeding via gastrostomy versus standard care in high risk patients with head and neck cancer

Brown, Teresa, Banks, Merrilyn, Hughes, Brett, Kenny, Lizbeth, Lin, Charles and Bauer, Judith (2014) Protocol for a randomized controlled trial of early prophylactic feeding via gastrostomy versus standard care in high risk patients with head and neck cancer. BMC Nursing, 13 1: 17.1-17.10. doi:10.1186/1472-6955-13-17


Author Brown, Teresa
Banks, Merrilyn
Hughes, Brett
Kenny, Lizbeth
Lin, Charles
Bauer, Judith
Title Protocol for a randomized controlled trial of early prophylactic feeding via gastrostomy versus standard care in high risk patients with head and neck cancer
Journal name BMC Nursing   Check publisher's open access policy
ISSN 1472-6955
Publication date 2014-07-01
Sub-type Article (original research)
DOI 10.1186/1472-6955-13-17
Open Access Status DOI
Volume 13
Issue 1
Start page 17.1
End page 17.10
Total pages 10
Place of publication London, United Kingdom
Publisher BioMed Central
Formatted abstract
Background: Patients with head and neck cancer are at high risk of malnutrition and dysphagia. Enteral tube feeding via a gastrostomy or nasogastric tube is often required in response to dysphagia, odynophagia or side effects of treatment that lead to dehydration and/or weight-loss. A recent systematic review concluded that the optimal method of tube feeding remains unclear; however prophylactic gastrostomy, placed in anticipation of its use during and after treatment, is common practice, following a number of demonstrated benefits. However the majority of these studies have been undertaken in patients receiving radiotherapy alone. More recent studies in patient populations receiving concurrent chemoradiotherapy are showing that despite prophylactic gastrostomy placement significant weight loss still occurs, placing the patient at risk of the consequences of malnutrition. Therefore we set out to investigate innovative prophylactic nutrition support via the gastrostomy to optimise the nutritional outcomes of patients with head and neck cancer.

Methods/Design: Patients with head and neck cancer will be eligible for this single centre randomised controlled trial if they are identified for referral for a prophylactic gastrostomy using local guidelines. Patients will be excluded if they are: under the age of eighteen; pregnant; unable to give informed consent; or severely malnourished or moderately malnourished with significant dysphagia requiring a liquid or puree diet. All eligible patients who consent for the study will be allocated randomly to either the intervention or control group (usual care). The intervention group will commence prophylactic supplementary nutrition support via the gastrostomy immediately following placement compared to usual care where nutrition support is commenced via the gastrostomy when clinically indicated during treatment. Key outcome measures will be percentage weight loss, body composition, nutritional status and quality of life, measured at baseline and three months post treatment.

Discussion: To our knowledge this is the first study to evaluate the effectiveness of early prophylactic tube feeding compared to commencement of feeding during treatment, as per current standard practice, in patients undergoing prophylactic gastrostomy prior to treatment for head and neck cancer.Trial registration: This trial has been registered in the Australian New Zealand Clinical Trials registry as ACTRN12612000579897.
Keyword Enteral nutrition
Gastrostomy
Head and neck cancer
Nutrition support
Prophylactic
Quality of life
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Human Movement and Nutrition Sciences Publications
 
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