| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN17506204 |
| Date ISRCTN assigned | 29/09/2006 |
| Local reference number(s) | N0077170542 |
| Public title | 'Prehab' or 'Rehab'? Minimising the loss of lean body mass after curative gastrointestinal resection and speeding rehabilitation by exercise and optimised nutrition |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer: Gastrointestinal |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics information provided as of 29 September 2006 |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/11/2005 |
| Anticipated end date | 01/10/2006 |
| Status of trial | Completed |
| Target number of participants | 76 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Derby Hospitals NHS Foundation Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof M Larvin |
| Contact details | Southern Derbyshire Acute Hospitals NHS Trust - DCGH
Derby City General Hospital
Uttoxeter Road
Derby
United Kingdom
DE22 3NE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN17506204 |
| Date last extracted from ISRCTN register | 17/04/2008 |
