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
Protocol serial number	N0258171429
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	The Royal Marsden NHS Foundation Trust (UK) - NHS R&D Support Funding

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Bowel toxicity (assessed using IBD-Q) at week 4 2. Small bowel damage (citrulline/faecal calprotectin) at week 2 and week 4
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/05/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes