Contact information
Type
Scientific
Primary contact
Dr Jervoise Andreyev
ORCID ID
Contact details
Department of Medicine
Royal Marsden NHS Foundation Trust
Fulham
London
SW10 9NH
United Kingdom
+44 (0)20 7808 2105
j@andreyev.demon.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CCR1999
Study information
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
Acronym
The NUT Study
Study hypothesis
Nutritional intervention in people with metastatic gastrointestinal malignancy is associated with survival benefit
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2002
Overall trial end date
01/12/2007
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
660
Participant exclusion criteria
Clinical condition precluding oral nutrition, unable to tolerate milk, being considered for immediate enteral or parenteral nutrition.
Recruitment start date
01/11/2002
Recruitment end date
19/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Marsden NHS Foundation Trust
London
SW10 9NH
United Kingdom
Sponsor information
Organisation
Royal Marsden NHS Foundation Trust (UK)
Sponsor details
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
+44 (0)20 8661 3882
jane.lawrence@rmh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Henry Smith Foundation and Dr J Andreyev's Research Fund (UK)
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://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=1911252
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21733143
Publication citations
-
Results
Baldwin C, Spiro A, McGough C, Norman AR, Gillbanks A, Thomas K, Cunningham D, O'Brien M, Andreyev HJ, Simple nutritional intervention in patients with advanced cancers of the gastrointestinal tract, non-small cell lung cancers or mesothelioma and weight loss receiving chemotherapy: a randomised controlled trial., J Hum Nutr Diet, 2011, 24, 5, 431-440, doi: 10.1111/j.1365-277X.2011.01189.x.