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
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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-nutrition-supplements-and-dietary-advice-for-people-due-to-have-chemotherapy-for-advanced-cancer

Contact information

Dr Jervoise Andreyev
Scientific

Department of Medicine
Royal Marsden NHS Foundation Trust
Fulham
London
SW10 9NH
United Kingdom

Phone +44 (0)20 7808 2105
Email j@andreyev.demon.co.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA 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 acronymThe NUT Study
Study objectivesNutritional 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) studiedCancer: Gastrointestinal
Intervention1. 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 typeOther
Primary outcome measureSurvival benefit related to nutritional intervention. Dietary advice to improve nutritional intake results in weight gain.
Secondary outcome measuresAny additional benefits when nutritional supplements are given with dietary advice.
Overall study start date01/01/2002
Completion date01/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants660
Key inclusion criteriaPatients 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 criteriaClinical condition precluding oral nutrition, unable to tolerate milk, being considered for immediate enteral or parenteral nutrition.
Date of first enrolment01/11/2002
Date of final enrolment19/10/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Marsden NHS Foundation Trust
London
SW10 9NH
United Kingdom

Sponsor information

Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre

Downs Road
Sutton, Surrey
SM2 5PT
England
United Kingdom

Phone +44 (0)20 8661 3882
Email jane.lawrence@rmh.nhs.uk
Website http://www.royalmarsden.nhs.uk/rmh
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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