Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
13/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof M Larvin

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust - DCGH
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077170542

Study information

Scientific title

Acronym

Study hypothesis

To determine if patients scheduled for a curative resection of a gastrointestinal tumour are able to overcome the demands of surgery and metabolic derangements associated with it, more easily, following an optimized nutrition and resistance training programme. The expediated rehabilitation will be judged by body composition, cardiovascular and muscle function and anabolic responses of muscle and whole body protein metabolism. They will be compared with patients receiving only the current best standard care.

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

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer: Gastrointestinal

Intervention

During a routine NHS 76 patients who have been identified as suitable patients at MDT meetings and are agreeable to participating will receive informed consent. Screening investigations will be performed.
Patients will be randomised into two groups; a treatment group and a control group. The treatment group will enter into an eight week fitness regimen consisting of resistance exercises for twenty minutes three times a week followed by a high energy/ high protein food bar.
The control group will receive advice on nutrition and exercise alone.
There will be two study days for all patients in the study. These will be separated and may be either pre and post intervention of pre and post operative.
On each study day DEXA scanning will be performed and fractional synthetic rate determined in fasted and fed states.
All subjects will attend 7 days after their last acute study. A general examination will be performed with particular attention pain to sites of cannulation and muscle biopsies.
Recent similar studies have attracted large numbers of patients, suggesting that they will be recruitable. Opinions from patients with gastrointestinal cancer have been obtained regarding the study design and information sheets.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Difference in factional synthetic rate as determined by incorporation of leucine and D%-Phenyalanine between treatment group and control group. Quantification of NFf>>B expression, mTOR and p70S6 kinase phosphorylation and protein expression in muscle samples by western analysis.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2005

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

During a routine NHS visit 76 patients who have been identified as suitable patients at multidisciplinary team (MDT) meetings and are agreeable to participating will receive informed consent.

Inclusion Criteria: patients with curative colonic cancer.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

76

Participant exclusion criteria

1. Metastatic disease
2. Too weak to manage the exercise
3. Unable to give informed consent
4. Patients with insufficient command of the English language
5. Patients taking steroids or betablockers

Recruitment start date

01/11/2005

Recruitment end date

01/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust - DCGH
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes