ENIGMA - modified fat - A randomised controlled trial using a modified fat diet in patients undergoing pelvic radiotherapy

ISRCTN	ISRCTN97949632
DOI	https://doi.org/10.1186/ISRCTN97949632
Secondary identifying numbers	N0258171429

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jervoise Andreyev
Scientific

Gastrointestinal Unit
Department of Medicine
Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom

Study design	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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Pelvic radiotherapy
Intervention	Randomised test intervention vs no intervention controls, non-blinded (Phase III)
Intervention type	Other
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 study start date	03/01/2006
Completion date	01/05/2007

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	105
Key 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
Key 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.
Date of first enrolment	03/01/2006
Date of final enrolment	01/05/2007

Gastrointestinal Unit

London
SW3 6JJ
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

The Royal Marsden NHS Foundation Trust (UK) - NHS R&D Support Funding

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2012		Yes	No