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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: |
ISRCTN35391431 |
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Date of registration:
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21/11/2005 |
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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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Assessment of the palatability of elemental nutritional supplements compared to non-elemental supplements in people with pelvic cancers and people without cancer, and whether this changes following treatment with radiotherapy
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Scientific title:
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Date of first enrolment:
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26/01/2004 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN35391431 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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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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Faculty of Medicine
Imperial College
Chelsea & Westminster Hospital
369 Fulham Road
SW10 9NH
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients about to embark on a course of radical pelvic radiotherapy for pelvic malignancy
Exclusion criteria: 1. Unwilling or unable to give informed consent to participate in the study
2. A clinical condition precluding oral feeding (e.g. dysphagia, bowel obstruction)
3. Unable to tolerate milk
4. Controls with a previous history of pelvic malignancy or currently receiving chemotherapy or radiotherapy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pelvic (gynaecological, urological or rectal) cancers
Cancer
Pelvic
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Intervention(s)
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Subjects were randomised to one of five groups. Each group was assigned a target quantity of 3 different elemental sip feeds (Group 1, 20%, Group 2, 50%, Group 3, 75% of calorie requirements taken as E028 extra liquid; Group 4, 50% of calorie requirements taken as E028 extra powder; Group 5, 50% of calorie requirements taken as Emsogen powder).
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Primary Outcome(s)
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Taste assessed by visual analogue scale
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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SHS International, Dr Andreyev's Personal Research Fund, Royal Marsden NHS Foundation Trust (UK)
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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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