None listed
Conditions
Brief summary
This study compares the effects of a specialised nutritional supplement to boost the immune system compared with the standard formula, both before and after surgery, in people undergoing major surgery for oesophageal cancer. You can participate in this study if you are scheduled to have oesophagectomy or oesophago-gastrectomy for oesophageal cancer. Participants will be randomly divided into one of four groups. One group will receive a nutritional supplement with added immunonutrition (IN) pre-surgery and the standard isocaloric nutritional supplement post surgery. A second group will receive IN both before and after surgery. The third group will receive the standard supplement prior to surgery and IN following surgery, whilst the fourth group will receive the standard formula both before and after surgery. Patients will be monitored at 7 and 1 day before surgery and 14 and 42 days after surgery. The study aims to see whether the IN product before and/or after surgery will decrease the rate of infective and non-infective complications that often occur in people undergoing this surgery.
Interventions
This study will be a multicentre, prospective, double blind, RCT with a 2 x 2 factorial design
Participants (N= 232) will be randomised to receive:
Arm 1: Pre-operative immunonutrition and post-operative immunonutrition (n=58)
Arm 2: Pre-operative immunonutrition and post-operative control nutrition (n=58)
Arm 3: Pre-operative control nutrition and post-operative immunonutrition (n=58)
Arm 4: Pre-operative control nutrition and post-operative control nutrition (n=58)
Pre-operative supplement-
This study will be a multicentre, prospective, double blind, RCT with a 2 x 2 factorial design Participants (N= 232) will be randomised to receive: Arm 1: Pre-operative immunonutrition and post-operative immunonutrition (n=58) Arm 2: Pre-operative immunonutrition and post-operative control nutrition (n=58) Arm 3: Pre-operative control nutrition and post-operative immunonutrition (n=58) Arm 4: Pre-operative control nutrition and post-operative control nutrition (n=58) Pre-operative supplement- Active Participants are required to consume orally, in addition to their normal diet, 3 x 74g sachets of pre-operative supplement to be dissolved in water up to 900ml for seven days prior to surgery (21 sachets total/ participant). Patients who have total dysphagia will be fed enterally (either nasoenteric or jejunostomy feeding tube). The oral immunonutrition supplement contains 909kCal, 50.4g total protein (includes 11.4g free L-arginine), 3.0g omega-3 fatty acids EPA, DHA and alpha linolenic acid (LNA) and 1.2g RNA per 900ml. Post-operative supplement- Active Patients will be fed the post-operative formula supplement for 7 days consecutive days after oesophagectomy via their jejunostomy which will be inserted during the oesophagectomy procedure. Feeding will commence on day +1 following surgery at a rate of 40ml/hr (for 24 hours) unless otherwise indicated by the treating surgeon or delegate. Feeds will be upgraded daily if tolerated in 20ml increments to the maximum rate required to meet 100% of their estimated postoperative energy and protein requirements or at the treating surgeon/ delegate’s discretion. The total volume of fluid should not exceed 90mls/hr without the treating surgeon/ delegate’s approval. The post-operative immunonutrition supplement formula contains 1010kCal, 56g total protein (includes 13g arginine), 3.3g omega-3 fatty acids EPA, DHA & LNA and 1.3g RNA per 1000ml.
Sponsors
Professor Glyn Jamieson
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically proven neoplasm of the oesophagus or gastro oesophageal junction Patients scheduled for oesophagectomy or oesophago-gastrectomy and insertion of a feeding jejunostomy
Exclusion criteria
Patients requiring parenteral nutrition Pregnancy Cognitive or other limitations preventing patient from being able to provide informed consent Taking fish oil or fish oil capsules, flaxseed oil or flaxseed capsules, cod liver oil or cod liver capsules or consuming products enriched with immunonutrients eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and arginine (e.g. ProSure or Resource Support or Forticare) within 2 weeks of the proposed surgery or not willing to cease these products at least 2 weeks prior to the proposed surgery.
Outcome results
None listed