Elemental Nutrition in Gastrointestinal symptom management during pelvic radiotherapy (enigma)
| ISRCTN | ISRCTN08312234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08312234 |
| Protocol serial number | N0258152650 |
| Sponsor | Department of Health |
| Funders | The Royal Marsden NHS Foundation Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open label controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Medicine Section
Sutton, Surrey
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
