Condition category
Cancer
Date applied
03/11/2011
Date assigned
23/01/2012
Last edited
17/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Sorrel Burden

ORCID ID

http://orcid.org/0000-0002-4967-647X

Contact details

Room 6.308
Jean Macfarlane Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 7856
sorrel.burden@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

101

Study information

Scientific title

A randomised controlled trial for Pre-operative Oral Supplementation in Colorectal Cancer patients

Acronym

POSiCC

Study hypothesis

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

NRES Committee- North West Liverpool East, 15 March 2012, ref: 12/NM/0208

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Fortisip Compact® , Fortijuice®

Primary outcome measures

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 trial start date

15/01/2012

Overall trial end date

30/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Reported weigh loss over the previous 6 months
2. Primary colorectal tumour, eligible for curative surgery
3. Informed consent gained

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

126

Participant 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

Recruitment start date

10/10/2012

Recruitment end date

22/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Room 6.308
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Macmillan Cancer Care (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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