CompletedPhase 2ACTRN12607000162415

Specialised nutrition in head and neck cancer surgery

A randomised Phase I/II trial to investigate the effects of immune-modulating nutritional supplements provided perioperatively to non-malnourished patients undergoing surgery for head and neck cancer on postoperative immune status and inflammation.


Sponsor

Dr Mark Izzard

Enrollment

30 participants

Start Date

Jun 11, 2007

Study Type

Interventional

Conditions

Summary

This is a study of specialised nutrition in people having surgery for head and neck cancer. Who is it for? You can join this study if you are undergoing major surgery for head and neck cancer and your doctor thinks you are not malnourished. Trial details Participants will be randomly divided into three groups. The different groups receive either: • preoperatively 5 days of oral IMPACT solution and postoperatively IMPACT enteral feeding. (IMPACT contains a number of supplements that may help the immune system.) • preoperatively 5 days of oral glutamine supplements and postoperative glutamine enteral feeding. (Glutamine may help the immune system.) • standard nutritional supplementation which usually involves no preoperative supplements and standard postoperative enteral feeding. The study looks at the effects of the different regimes. In particular it investigates postoperative immune and inflammatory status measured by blood tests on Days 1, 3, 5 and 7 after surgery. Standard postoperative care for people undergoing major surgery for head and neck cancer includes intensive nursing and medical care and enteral nutritional support. The trial includes different types of supplements which try and help the immune system. One of the trials uses the supplement IMPACT which contains a number of different supplements and the other uses glutamine. The supplements are given orally before the surgery and enterally after the surgery. The blood test results will provide the foundation for a larger scale study with infectious complications and nutritional status as major endpoints.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study examines whether specialized nutrition support before and after head and neck cancer surgery improves recovery. This study is open to both men and women aged 16 and older. You would receive a tailored nutrition plan and be monitored for recovery outcomes after surgery.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Three-arm study: IMPACT group receives 5 days standard ORAL IMPACT (Novartis, 3 sachets/d, each sachet of 74g contains 3.8g arginine, 0.4 g nucleotides, 1.0 g eicosapentaenoic acid (EPA) and docosa

Three-arm study: IMPACT group receives 5 days standard ORAL IMPACT (Novartis, 3 sachets/d, each sachet of 74g contains 3.8g arginine, 0.4 g nucleotides, 1.0 g eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) preoperatively and standard enteral IMPACT postoperatively commencing as soon as possible, within clinical guidelines, after surgery up to full caloric requirements for 5 days. Glutamine group receives 5 days oral lutamine (30g/d, Glutaminox, Oxford Nutrition) preoperatively and glutamine enriched (30g/d) standard enteral feed postoperatively commencing as soon as possible, within clinical guidelines, after surgery up to full caloric requirements for 5 days. .


Locations(1)

New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12607000162415