Elemental Nutrition in Gastrointestinal symptom management during pelvic radiotherapy (enigma)
| ISRCTN | ISRCTN08312234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08312234 |
| Secondary identifying numbers | N0258152650 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 10/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jervoise Andreyev
Scientific
Scientific
Medicine Section
Royal Marsden NHS Trust
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8643 8901 |
|---|
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | ENiGMa |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 102 |
| Key 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). |
| Key exclusion criteria | 1. Patients with condition precluding oral nutrition 2. Patients undergoing conformal radiotherapy or intra-cavity brachytherapy 3. Patients with clotting disorders |
| Date of first enrolment | 25/11/2004 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medicine Section
Sutton, Surrey
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The Royal Marsden NHS Foundation Trust (UK)
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2008 | Yes | No |
