RecruitingACTRN12611000178943

Comparison of pre- and peri operative immunonutrition to standard formula in patients undergoing surgical resection of oesophageal cancer

The effect of pre- and perioperative immunonitrition versus standard formula on post-operative complications, mortality, length of stay, quality of life and nutritional outcomes in patients undergoing surgical resection of oesophageal cancer

Sponsor

Professor Glyn Jamieson

Enrollment

232 participants

Start Date

Aug 9, 2010

Study Type

Interventional

Conditions

Patients undergoing oesophagectomy for cancer resection

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Surgery to remove esophageal cancer (cancer of the food pipe) is a major operation that carries a risk of serious complications, including infections. This study is testing whether a special nutritional supplement called immunonutrition (IN) — which contains ingredients like omega-3 fatty acids and arginine that are thought to strengthen the immune system — can lower the risk of complications when given before and/or after surgery. There are four groups in the study, each receiving IN either before, after, both before and after, or not at all. You may be eligible if: - You have been diagnosed with esophageal cancer or cancer at the junction of the esophagus and stomach (confirmed by biopsy) - You are scheduled for surgical removal of the esophagus (esophagectomy or esophago-gastrectomy) and a feeding tube into the intestine (jejunostomy) You may NOT be eligible if: - You need nutrition delivered directly into a vein (parenteral nutrition) rather than through the gut - You are pregnant - You have difficulty understanding and giving consent due to cognitive limitations - You are currently taking fish oil, flaxseed oil, or similar immune-boosting supplements, or are unwilling to stop taking them at least 2 weeks before surgery Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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-

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.

Locations(1)

QLD,SA, Australia

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ACTRN12611000178943