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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN97949632 |
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Date of registration:
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29/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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ENIGMA - modified fat - A randomised controlled trial using a modified fat diet in patients undergoing pelvic radiotherapy
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Scientific title:
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Date of first enrolment:
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03/01/2006 |
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Target sample size:
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105 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN97949632 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Jervoise
Andreyev |
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Address:
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Gastrointestinal Unit
Department of Medicine
Royal Marsden NHS Trust
Fulham Road
SW3 6JJ
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer: Pelvic radiotherapy
Cancer
Malignant neoplasm of other and ill-defined sites
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Intervention(s)
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Randomised test intervention vs no intervention controls, non-blinded (Phase III)
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Primary Outcome(s)
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1. Bowel toxicity (assessed using IBD-Q) at week 4
2. Small bowel damage (citrulline/faecal calprotectin) at week 2 and week 4
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0258171429
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Source(s) of Monetary Support
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The Royal Marsden NHS Foundation Trust (UK) - NHS R&D Support Funding
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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