None listed
Conditions
Brief summary
The primary purpose of this study is to determine whether a very low energy diet (VLED) can reduce weight and improve outcomes in obese patients undergoing surgery for rectal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over with a BMI greater than or equal to 30 and have been diagnosed with adenocarcinoma of the rectum for which surgery has been prescribed. Study details Participants will be randomly allocated (by chance) to either the Optifast diet treatment, or the usual care treatment. Participants on the Optifast diet treatment will be restricted to 800 calories or less per day for 4 - 6 weeks before the surgery, using the Optifast diet products including nutritionally complete soup sand shakes. Participants in the usual care treatment group will receive care and advice prior to their surgery as normal. Patient outcomes will then be assessed at visits in the hospital stay at day three, then at day 14, four to six weeks, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after discharge. Further long-term follow-up will be conducted annually for an additional three (3) years after the 24 months follow up visit at which participants will undergo a blood sample and physical examination. It is hoped that the findings of this trial will increase understanding of the potential benefits of a VLED prior to surgery in obese patients with rectal cancers.
Interventions
The VLED will be using the Optifast product which is an oral, nutritionally complete, very low calorie diet and limits energy intake to less than 800 calories per day.This involves the use of soups and shakes plus low starch vegetables, calorie free fluids and calorie free lollies and mints in small amounts.The duration is 4-6 weeks prior to surgery.The patients will keep a food diary to monitor adherence..
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histological diagnosis of adenocarcinoma of the rectum (where the distal margin of the tumour is less than 15cm from the anal verge as measured at rigid sigmoidoscopy). T 1-3 N0 M0, T1-3 N1 M0 or T1-3 N0-1 M1 disease as determined by pre-treatment CT scans and or pelvic MRI (or endorectal ultrasound if MRI contraindicated) for rectal cancers. Body Mass Index (BMI) greater than or equal to 30. Age greater than or equal to 18 years. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0, 1 or 2. Able and willing to provide written informed consent Ability to comply with the study protocol (as judged by the responsible surgeon) Life expectancy of at least 12 weeks.
Exclusion criteria
Pregnancy or breast feeding. Any uncontrolled concurrent medical condition. Any co-morbid disease that would increase risk of morbidity. Participation in any investigational drug study within the previous 4 weeks. Evidence of T4 disease extending to circumferential margin of rectum or invading adjacent organs. Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, or other severe incapacitating disease, i.e. ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation). History of conditions that would preclude use of a laparoscopic approach (e.g. multiple previous major laparotomies, severe adhesions). Concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration. Short course radiotherapy
Outcome results
None listed