'Prehab' or 'Rehab'? Minimising the loss of lean body mass after curative gastrointestinal resection and speeding rehabilitation by exercise and optimised nutrition

ISRCTN	ISRCTN17506204
DOI	https://doi.org/10.1186/ISRCTN17506204
Secondary identifying numbers	N0077170542

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 28/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof M Larvin
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	'Prehab' or 'Rehab'? Minimising the loss of lean body mass after curative gastrointestinal resection and speeding rehabilitation by exercise and optimised nutrition
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/11/2005
Completion date	01/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	76
Key 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.
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	01/10/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southern Derbyshire Acute Hospitals NHS Trust - DCGH

Derby
DE22 3NE
United Kingdom

Sponsor information

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

28/02/2020: No publications found. All search options exhausted.