Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
12/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.royalmarsden.nhs.uk/rmh

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

  1. 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.

Additional files

Editorial Notes