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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN08312234 |
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Date of registration:
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30/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Elemental Nutrition in Gastrointestinal symptom management during pelvic radiotherapy (enigma)
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Scientific title:
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Date of first enrolment:
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25/11/2004 |
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Target sample size:
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102 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN08312234 |
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Study type:
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Interventional |
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Study design:
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Randomised open label controlled parallel group trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Jervoise
Andreyev |
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Address:
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Medicine Section
Royal Marsden NHS Trust
Downs Road
SM2 5PT
Sutton, Surrey
United Kingdom |
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Telephone:
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+44 (0)20 8643 8901 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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).
Exclusion criteria: 1. Patients with condition precluding oral nutrition
2. Patients undergoing conformal radiotherapy or intra-cavity brachytherapy
3. Patients with clotting disorders
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Pelvic cancers
Cancer
Malignant neoplasm of other or ill-defined sites
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Intervention(s)
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Randomised test intervention versus no intervention controls, non-blinded Phase III
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0258152650
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Source(s) of Monetary Support
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The Royal Marsden NHS Foundation Trust (UK), NHS R&D Support Funding
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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