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
Protocol serial number	CCR1999
Sponsor	Royal Marsden NHS Foundation Trust (UK)
Funder	Henry Smith Foundation and Dr J Andreyev's Research Fund (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Survival benefit related to nutritional intervention. Dietary advice to improve nutritional intake results in weight gain.
Key secondary outcome measure(s)	Any additional benefits when nutritional supplements are given with dietary advice.
Completion date	01/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Royal Marsden NHS Foundation Trust

London
SW10 9NH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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