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Trial registered on ANZCTR


Registration number
ACTRN12616001621404p
Ethics application status
Submitted, not yet approved
Date submitted
18/11/2016
Date registered
23/11/2016
Date last updated
23/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The IMPACT of preoperative immunonutrition in patients undergoing surgery for colorectal cancer
Scientific title
The IMPACT of preoperative immunonutrition on infectious complications in patients undergoing surgery for colorectal cancer
Secondary ID [1] 290563 0
Nil known
Universal Trial Number (UTN)
U1111-1189-9603
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 301006 0
Condition category
Condition code
Surgery 300803 300803 0 0
Other surgery
Cancer 300839 300839 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IMPACT Advanced Recovery is a beverage made by Nestle which contains special nutrients (immunonutrients) which may enhance the immune system in patients having major surgery, improving patient recovery. In our treatment group, patients undergoing surgery for colorectal (bowel) cancer will be given a pamphlet containing information on healthy eating for surgery, as well as IMPACT Advanced Recovery drinks to consume before the operation. These participants will be instructed to take 3 x 237 mL drink packs a day, for 5 consecutive days before their operation, with the last drink to be taken two days before their operation.

The ingredients in IMPACT Advanced Recovery (Vanilla) are: Water, Sugar, Calcium caseinate (milk), Sodium caseinate, L-arginine, Refined fish oil (anchovy, sardine) and less than 2% of corn oil, Citric acid, Medium chain triglycerides, Maltodextrin, Natural and artificial flavor, Yeast extract, Potassium citrate, Potassium chloride, Calcium phosphate, Magnesium phosphate, Salt, Magnesium chloride, Cellulose gel, Cellulose gum, Choline chloride, Sodium ascorbate, Sucralose (sweetener), Carrageenan, Zinc sulfate, Ferrous sulfate, D-alpha-tocopherol, Niacinamide, Soybean oil, Dl-alpha tocopheryl acetate, Calcium pantothenate, Copper gluconate, Manganese sulfate, Vitamin A palmitate, Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, Beta-carotene, Folic acid, Potassium iodide, Sodium selenite, Sodium molybdate, Chromium chloride, Vitamin K1, Biotin, Vitamin D3, Vitamin B12.

The pamphlet for the treatment group provides the same information as the control pamphlet, as well as information on what IMPACT Advanced Recovery is, its ingredients and reported benefits, and how to take it before one's operation. These pamphlets have been made specifically for this study by Bankstown-Lidcombe Hospital's Nutrition and Dietetics department.

Adherence to the intervention will be monitored by use of a chart given to each participant in the treatment group, which will contain checkboxes for each day and time at which the participant is to take the IMPACT Advanced Recovery drink. In addition to this, participants will also be instructed to return any unconsumed packs.
Intervention code [1] 296427 0
Treatment: Other
Comparator / control treatment
Patients undergoing surgery for colorectal (bowel) cancer will be given a pamphlet containing information on healthy eating for surgery. This pamphlet explains why special attention to one's diet before surgery is important. It highlights the benefits to post-operative healing of eating protein at each meal, encourages a variety of nutritious foods as well as maintenance of one's weight, provides further information on extra considerations for diabetic patients, as well as advice to drink enough water and to fast for one's operation as directed.
Control group
Active

Outcomes
Primary outcome [1] 300243 0
Number of infectious complications will be calculated by reviewing medical records, and classified using the Centers for Disease Control and Prevention classification: superficial incisional, deep incisional or organ/space infection.
Timepoint [1] 300243 0
30 days post-operatively
Secondary outcome [1] 329477 0
Total post-operative complications will be measured using the Clavien-Dindo classification of surgical complications
Timepoint [1] 329477 0
30 days post-operatively
Secondary outcome [2] 329478 0
Length of hospital stay will be measured in days. This refers only to the index admission.
Timepoint [2] 329478 0
30 days post-operatively
Secondary outcome [3] 329479 0
Number of tumour infiltrating lymphocytes (TILs) in operative specimen
Timepoint [3] 329479 0
Measured once in the specimen which is removed in the operation
Secondary outcome [4] 329541 0
CD4 count will be measured using blood samples
Timepoint [4] 329541 0
Pre-operative, then days 1, 4 and 7 post-operatively
Secondary outcome [5] 329542 0
CD8 count will be measured using blood samples
Timepoint [5] 329542 0
Pre-operative, then days 1, 4 and 7 post-operatively
Secondary outcome [6] 329543 0
CD4:CD8 ratio will be measured using blood samples
Timepoint [6] 329543 0
Pre-operative, then days 1, 4 and 7 post-operatively
Secondary outcome [7] 329544 0
Prealbumin will be measured using serum samples
Timepoint [7] 329544 0
Pre-operative, then days 1, 4 and 7 post-operatively
Secondary outcome [8] 329545 0
Interleukin-6 will be measured using serum samples
Timepoint [8] 329545 0
Pre-operative, then days 1, 4 and 7 post-operatively
Secondary outcome [9] 329546 0
TNF-alpha will be measured using serum samples
Timepoint [9] 329546 0
Pre-operative, then days 1, 4 and 7 post-operatively
Secondary outcome [10] 329547 0
White cell count will be measured using blood samples
Timepoint [10] 329547 0
Pre-operative, then days 1, 4 and 7 post-operatively
Secondary outcome [11] 329548 0
C-reactive protein will be measured using serum samples
Timepoint [11] 329548 0
Pre-operative, then days 1, 4 and 7 post-operatively

Eligibility
Key inclusion criteria
Histological diagnosis of colorectal cancer
Planned for elective curative surgery
Able to give informed consent
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Ongoing infection
Emergency operation
Clinical and/or radiological evidence of bowel obstruction
Widespread metastatic disease
Preexisting severe Respiratory dysfunction (pO2 < 75 mmHg), Cardiac dysfunction (NYHA Class greater than or equal to 3), Renal dysfunction (on haemodialysis) and/or Hepatic dysfunction (Child Class C).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomisation sequence will be used to label opaque envelopes, already containing information about which arm the receiving participant will be allocated to, in sequence from 1 - 136.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation sequence will be generated using the tool provided at http://randomizer.org. This sequence will be used to label the opaque envelopes described above.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The infective complications rate for patients undergoing colorectal resections in Bankstown is around 30%. To demonstrate a reduction in infectious complications to 10% from preoperative immunonutrition, 62 patients are needed in each arm. This was calculated using an alpha of 5% and power of 80%. Assuming around 10% of patients with breach of protocol or not proceeding to elective surgery, this brings the total required to 136.

The statistical software to be used is SPSS. T-test will be used for age, Chi squared test for proportions, and Wilcoxon Rank Sum test for non-parametric data. Differences will be considered significant where the probability is less than 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2016
Actual
Date of last participant enrolment
Anticipated
20/06/2018
Actual
Date of last data collection
Anticipated
20/07/2018
Actual
Sample size
Target
136
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6949 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 14639 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 294999 0
Hospital
Name [1] 294999 0
Bankstown-Lidcombe Hospital
Country [1] 294999 0
Australia
Primary sponsor type
Individual
Name
Soondoos Raashed
Address
Bankstown-Lidcombe Hospital
70 Eldridge Road
Bankstown NSW 2200
Country
Australia
Secondary sponsor category [1] 293816 0
Individual
Name [1] 293816 0
Matthew Morgan
Address [1] 293816 0
Bankstown-Lidcombe Hospital
70 Eldridge Road
Bankstown NSW 2200
Country [1] 293816 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296353 0
SWSLHD Human Research Ethics Committee
Ethics committee address [1] 296353 0
Ethics committee country [1] 296353 0
Australia
Date submitted for ethics approval [1] 296353 0
26/09/2016
Approval date [1] 296353 0
Ethics approval number [1] 296353 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70554 0
Dr Soondoos Raashed
Address 70554 0
Department of Surgery
Bankstown-Lidcombe Hospital
70 Eldridge Road
Bankstown NSW 2200
Country 70554 0
Australia
Phone 70554 0
+61 2 9722 8000
Fax 70554 0
Email 70554 0
[email protected]
Contact person for public queries
Name 70555 0
Soondoos Raashed
Address 70555 0
Department of Surgery
Bankstown-Lidcombe Hospital
70 Eldridge Road
Bankstown NSW 2200
Country 70555 0
Australia
Phone 70555 0
+ 61 2 9722 8000
Fax 70555 0
Email 70555 0
[email protected]
Contact person for scientific queries
Name 70556 0
Soondoos Raashed
Address 70556 0
Department of Surgery
Bankstown-Lidcombe Hospital
70 Eldridge Road
Bankstown NSW 2200
Country 70556 0
Australia
Phone 70556 0
+61 2 9722 8000
Fax 70556 0
Email 70556 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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