Pre-operative oral supplementation in colorectal cancer patients

ISRCTN	ISRCTN02466810
DOI	https://doi.org/10.1186/ISRCTN02466810
Secondary identifying numbers	101

Submission date: 03/11/2011
Registration date: 23/01/2012
Last edited: 05/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-food-supplement-drinks-people-bowel-cancer-related-weight-loss-posicc

Contact information

Dr Sorrel Burden
Scientific

Room 6.308
Jean Macfarlane Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0002-4967-647X
Phone	+44 (0)161 306 7856
Email	sorrel.burden@manchester.ac.uk

Study information

Study design	Pragmatic randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial for Pre-operative Oral Supplementation in Colorectal Cancer patients
Study acronym	POSiCC
Study objectives	Do oral nutritional supplements and dietary advice compared to dietary advice alone improve clinical outcomes in weight losing colorectal cancer patients? Are oral supplements and dietary advice cost effective for weight losing colorectal cancer patients compared to dietary advice alone?
Ethics approval(s)	NRES Committee- North West Liverpool East, 15 March 2012, ref: 12/NM/0208
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	The intervention will be in the form of an oral supplement, if patients can tolerate milky drinks Fortisip Compact® (Nutricia Clinical Care) will be used. Patients will be offered a minimum of 250mls of supplement daily (2.4Kcals or 10.1KJ and 0.096g of protein per ml). If patients cannot tolerate milky drinks they will be offered Fortijuice® as an alternative (Nutricia Clinical Care) and asked to consume 400mls of supplement per day (1.5Kcals or 6.3KJ and 0.04g protein per ml, Fortijuce®). Patients will be started on the sip feed at the point of diagnosis of a colorectal tumour and when surgery is considered likely to be the treatment option. It is anticipated that the patients will receive the oral supplement for a minimum of two weeks and a maximum of 12 weeks. Patients will be asked to take the supplement up until they are placed on the preoperative carbohydrate drinks prior to surgery. Patients randomised will either be given dietary advice or oral supplements and dietary advice. The dietary advice will be to increase calories and protein in the diet. Patients will be given a diet sheet on increasing energy and protein in the diet. This advice is appropriate for weight losing patients preoperatively.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fortisip Compact® , Fortijuice®
Primary outcome measure	Number of postoperative chest and surgical site infections after CRC surgery, measured from patient medical records reviewed within 30 days after surgery.
Secondary outcome measures	As of 17/03/2016: 1. Total complications measured up to 30 days postoperatively 2. Anthropometry 3. Body composition and dietary intake Measured at baseline, 2-3 days preoperatively (where possible) and 7-10 days postoperatively (where possible). Initial 1. Anthropometry height, weight, body mass index, mid arm circumference (MAC) and skin fold thickness 2. Hand grip strength 3. Co-morbidities 4. 24 hour recalls to assess energy and protein 5. Hospital anxiety and depression score Measured at baseline, 24 hours preoperatively, 7 days post-operatively and at 3 months
Overall study start date	15/01/2012
Completion date	30/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	126
Key inclusion criteria	1. Reported weigh loss over the previous 6 months 2. Primary colorectal tumour, eligible for curative surgery 3. Informed consent gained
Key exclusion criteria	1. Pregnant or enrolled in another trial 2. Pacemaker and any metallic implant will preclude individuals from bioelectrical impedance monitoring 3. Cannot give informed consent
Date of first enrolment	10/10/2012
Date of final enrolment	22/01/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Room 6.308

Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

c/o Dr Karen Shaw
Head of Research Office
Manchester
M13 9PL
England
United Kingdom

"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Charity

Macmillan Cancer Care (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/06/2017		Yes	No

Editorial Notes

05/06/2019: Cancer Research UK lay results summary link added to Results (plain English).
25/05/2018: Publication reference added.
17/03/2016: Verified study information with principal investigator. Outcome measures have been amended. Recruitment start date has been changed from 15/01/2012 to 10/10/2012. Recruitment end date has been changed from 30/12/2013 to 22/01/2015
25/02/2016: No publications found, verifying study status with principal investigator