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
ISRCTN | ISRCTN86266498 |
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DOI | https://doi.org/10.1186/ISRCTN86266498 |
Secondary identifying numbers | CCR1999 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 12/06/2015
- 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
Contact information
Dr Jervoise Andreyev
Scientific
Scientific
Department of Medicine
Royal Marsden NHS Foundation Trust
Fulham
London
SW10 9NH
United Kingdom
Phone | +44 (0)20 7808 2105 |
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j@andreyev.demon.co.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | 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 |
Study acronym | The NUT Study |
Study objectives | Nutritional intervention in people with metastatic gastrointestinal malignancy is associated with survival benefit |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Cancer: Gastrointestinal |
Intervention | 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 |
Intervention type | Other |
Primary outcome measure | Survival benefit related to nutritional intervention. Dietary advice to improve nutritional intake results in weight gain. |
Secondary outcome measures | Any additional benefits when nutritional supplements are given with dietary advice. |
Overall study start date | 01/01/2002 |
Completion date | 01/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 660 |
Key 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. |
Key exclusion criteria | Clinical condition precluding oral nutrition, unable to tolerate milk, being considered for immediate enteral or parenteral nutrition. |
Date of first enrolment | 01/11/2002 |
Date of final enrolment | 19/10/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Marsden NHS Foundation Trust
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Sponsor information
Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Downs Road
Sutton, Surrey
SM2 5PT
England
United Kingdom
Phone | +44 (0)20 8661 3882 |
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jane.lawrence@rmh.nhs.uk | |
Website | http://www.royalmarsden.nhs.uk/rmh |
https://ror.org/0008wzh48 |
Funders
Funder type
Charity
Henry Smith Foundation and Dr J Andreyev's Research Fund (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 1. results | 01/05/2008 | Yes | No | |
Results article | results | 01/10/2011 | Yes | No |