Condition category
Cancer
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
10/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jervoise Andreyev

ORCID ID

Contact details

Medicine Section
Royal Marsden NHS Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
+44 (0)20 8643 8901

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes