None listed
Conditions
Brief 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.
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 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
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. .
Sponsors
Dr Mark Izzard
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Scheduled for radical resection of cancers of the oral cavity, pharynx and larynx.
Exclusion criteria
Patients will be excluded if pregnant, diabetic, on immunosuppressants, have had previous wide-field radical radiotherapy for head and neck cancer, or have greater than 10% weight loss.
Outcome results
None listed