Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0258171429
Study information
Scientific title
Acronym
Study hypothesis
Can a low fat diet (made up of 'normal' or 'long chain' fats) or a low fat diet containing additional 'medium chain' fats prevent or reduce bowel side effects in people undergoing a course of pelvic radiotherapy.
Ethics approval
Not provided at time of registration
Study design
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
Cancer: Pelvic radiotherapy
Intervention
Randomised test intervention vs no intervention controls, non-blinded (Phase III)
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
1. Bowel toxicity (assessed using IBD-Q) at week 4
2. Small bowel damage (citrulline/faecal calprotectin) at week 2 and week 4
Secondary outcome measures
Not provided at time of registration
Overall trial start date
03/01/2006
Overall trial end date
01/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients who are about to undergo a course of radical or adjuvant pelvic radiotherapy for gynaecological, urological or lower gastrointestinal malignancy
2. Patients able to give informed consent to participate
3. Patients with healthy liver function
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
105
Participant exclusion criteria
1. Patients unable or unwilling to give informed consent
2. Patients who have already started radiotherapy
3. Patients who have a condition precluding sage oral nutrition
4. Patients with compromised liver function
5. Urology patients participating in the IMRT clinical trial.
Recruitment start date
03/01/2006
Recruitment end date
01/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gastrointestinal Unit
London
SW3 6JJ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Royal Marsden NHS Foundation Trust (UK) - NHS R&D Support Funding
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22515941
Publication citations
-
Results
Wedlake LJ, McGough C, Shaw C, Klopper T, Thomas K, Lalji A, Dearnaley DP, Blake P, Tait D, Khoo VS, Andreyev HJ, Clinical trial: Efficacy of a low or modified fat diet for the prevention of gastrointestinal toxicity in patients receiving radiotherapy treatment for pelvic malignancies., J Hum Nutr Diet, 2012, 25, 3, 247-259, doi: 10.1111/j.1365-277X.2012.01248.x.