Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0258152650
Study information
Scientific title
Acronym
ENiGMa
Study hypothesis
To identify in patients having pelvic readiotherapy if elemental diet given for 3 weeks can reduce bowel symptoms and change other indicators of these symptoms.
Ethics approval
Not provided at time of registration
Study design
Randomised open label controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pelvic cancers
Intervention
Randomised test intervention versus no intervention controls, non-blinded Phase III
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
To assess bowel toxicity using IBDQ and to assess whether there are differences in the score in patients in their intervention arm and the control.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
25/11/2004
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
102 RMH patients, with a diagnosis of gynaecological or urological malignancy.
Will be undergoing a course of radical or adjuvant pelvic radiotherapy to a curative dose (including patients undergoing concomitant chemotherapy).
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
102
Participant exclusion criteria
1. Patients with condition precluding oral nutrition
2. Patients undergoing conformal radiotherapy or intra-cavity brachytherapy
3. Patients with clotting disorders
Recruitment start date
25/11/2004
Recruitment end date
31/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medicine Section
Sutton, Surrey
SM2 5PT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18315590
Publication citations
-
Results
McGough C, Wedlake L, Baldwin C, Hackett C, Norman AR, Blake P, Harrington K, Tait D, Khoo V, Frost G, Andreyev HJ, Clinical trial: normal diet vs. partial replacement with oral E028 formula for the prevention of gastrointestinal toxicity in cancer patients undergoing pelvic radiotherapy., Aliment. Pharmacol. Ther., 2008, 27, 11, 1132-1139, doi: 10.1111/j.1365-2036.2008.03665.x.