Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Primary outcome measure
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 study start date
25/11/2004
Overall study end date
31/07/2006
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study 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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2008 | Yes | No |