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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN97949632
Enrollment
105
Registered
2006-09-29
Start date
2006-01-03
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer: Pelvic radiotherapy Cancer Malignant neoplasm of other and ill-defined sites

Interventions

Randomised test intervention vs no intervention controls, non-blinded (Phase III)

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1. Bowel toxicity (assessed using IBD-Q) at week 4 2. Small bowel damage (citrulline/faecal calprotectin) at week 2 and week 4

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026