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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list