None listed
Conditions
Brief summary
This study looks at the effectiveness of early post-operative enteral (tube) feeding in people with advanced epithelial ovarian cancer. Who is it for? You can join this study if are a woman with primary ovarian, fallopian tube and peritoneal cancer who has undergone primary surgery to reduce the cancer. Trial details Participants will be divided into two groups. One group will receive standard postoperative care combined with early enteral feeding (feeding with a tube into the stomach). The other group will receive standard postoperative care only. Participants will be monitored for quality of life 6 weeks after surgery (at least a 10 point difference on the Functional Assessment of Cancer-General (FACT-G) quality of life instrument). The study aims to determine if early nutrition using a feeding tube has an impact on quality of life, length of hospital admission, recovery from surgery, complications from surgery, need for intravenous fluids after surgery, dosage of chemotherapy, nutritional status and ultimately a reduction in treatment costs.
Interventions
Postoperative enteral feeding plus standard postoperative diet.
During surgery an enteral feeding tube will be inserted through the patient's nose into their small bowel. The location of the feeding tube is checked by the surgeon via palpation intra-operatively, as well as by plain x-ray postoperatively. A standard fibre containing enteral nutrition formula (4.2kJ/ml) will be fed through the nasojejunal tube postoperatively. Feeding will commence at a rate of 40mls/hr 4 hours after return to
Postoperative enteral feeding plus standard postoperative diet. During surgery an enteral feeding tube will be inserted through the patient's nose into their small bowel. The location of the feeding tube is checked by the surgeon via palpation intra-operatively, as well as by plain x-ray postoperatively. A standard fibre containing enteral nutrition formula (4.2kJ/ml) will be fed through the nasojejunal tube postoperatively. Feeding will commence at a rate of 40mls/hr 4 hours after return to ward after surgery. Feeds will remain at this rate for the first 24 hours. The following day, feed rates will be increased to an individualised goal. The goal of enteral nutrition is to provide patients with 125 kilojoules per kilogram of body weight (adjusted using standard methodology for overweight patients). Patients randomised to early postoperative enteral feeding will be monitored daily by a nutritionist and will have their diet modified accordingly. Patients randomised to postoperative enteral feeding can also commence standard postoperative diet on return to ward. This usually involves sips of water and clear fluid commencing on the return to the ward after surgery. This "standard diet" may vary slightly from institution to institution.
Sponsors
Queensland Centre for Gynaecological Cancer
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients requiring planned upfront or interval cytoreductive surgery for suspected or histologically proven advanced ovarian, primary peritoneal cancer or fallopian tube cancer as determined jointly by the surgeon and the patient. Signs of moderate or severe malnutrition. Patient Generated Subjective Global Assessment (PG-SGA) category B or C Medically fit for cytoreductive surgery Signed written informed consent form Females aged 18 years or older Able to understand and complete questionnaires in English
Exclusion criteria
Other histological type than epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer Recurrent epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer Pre-existing contraindications to enteral nutrition such as ileus, gastrointestinal ischaemia, bilious or persistent vomiting or mechanical obstruction. Positive urinary pregnancy test 10 days prior to surgery in a pre-menopausal lady and/or women <2years after menopause who are not surgically sterile.
Outcome results
None listed