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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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17 October 2016 |
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Main ID: |
ISRCTN86266498 |
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Date of registration:
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12/09/2003 |
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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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A multicentre randomised controlled trial of nutritional intervention for patients with weight loss who are undergoing chemotherapy for gastrointestinal (GI) Malignancy, Non Small Cell Lung cancer (NSCL) or Mesothelioma
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Scientific title:
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A multicentre randomised controlled trial of nutritional intervention for patients with weight loss who are undergoing chemotherapy for gastrointestinal (GI) Malignancy, Non Small Cell Lung cancer (NSCL) or Mesothelioma |
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Date of first enrolment:
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01/11/2002 |
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Target sample size:
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660 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN86266498 |
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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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Not Specified
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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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Jervoise
Andreyev |
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Address:
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Department of Medicine
Royal Marsden NHS Foundation Trust
Fulham
SW10 9NH
London
United Kingdom |
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Telephone:
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+44 (0)20 7808 2105 |
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Email:
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j@andreyev.demon.co.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients who have agreed to undergo chemotherapy for histologically proven metastatic or locally advanced tumours in the gastrointestinal tract who are fit for chemotherapy and have weight loss defined by at least one of the following criteria: Body Mass Index <20 kg/m^2, weight loss of 55 or more over 3 months or greater, body weight of 5% or more below ideal body weight.
Exclusion criteria: Clinical condition precluding oral nutrition, unable to tolerate milk, being considered for immediate enteral or parenteral nutrition.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer: Gastrointestinal
Cancer
Gastrointestinal
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Intervention(s)
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1. Dietary advice to increase food intake by 600 calories
2. Dietary advice to increase intake by 600 calories plus oral supplement drink providing 588 calories plus mineral and vitamin supplement
3. Supplement drink plus vitamin and mineral supplement but no dietary advice
4. No dietary advice or supplements
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Primary Outcome(s)
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Survival benefit related to nutritional intervention. Dietary advice to improve nutritional intake results in weight gain.
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Secondary Outcome(s)
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Any additional benefits when nutritional supplements are given with dietary advice.
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Source(s) of Monetary Support
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Henry Smith Foundation and Dr J Andreyev's Research Fund (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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