ENeRgy Trial
Research type
Research Study
Full title
ENeRgy: Exercise and Nutritional Rehabilitation in patients with advanced cancer: randomised (1:1)unblinded feasibility trial of rehabilitation programme (exercise and nutrition) versus waiting list control, in patients with advanced cancer
IRAS ID
233125
Contact name
Barry J.A. Laird
Contact email
Sponsor organisation
ACCORD: Academic and Clinical Central Office for Research and Development
Duration of Study in the UK
1 years, 9 months, 10 days
Research summary
In patients with incurable cancer, general deterioration in their ability to walk, exercise and care for themselves is often regarded as an inevitable consequence of this. In 2015, Hospice UK published a report advocating "Rehabilitative Palliative Care”. The idea being that we should pursue the doctrines set by Dame Cicely Saunders over 40 years ago, that patients should live as fully as they can until they die.
However there is limited robust evidence on which to base this approach. Reviews of the literature show limited study numbers but do suggest that rehabilitation may be feasible for advanced cancer patients. However key components were not clear and no recommendations could be given.
This trial is designed primarily to test the feasibility of a rehabilitation programme (exercise and nutritional supplementation) in advanced cancer patients. Feasibility measures will be assessed including rates of recruitment and compliance. Other measures include impact on physical function, nutritional status, quality of life for patients and their carers. We will also assess the health economic impact by assessing patient health facility use throughout the trial.
40 patients with advanced cancer living in the community will be recruited from two hospice palliative care teams in Edinburgh. These patients will be randomised in to either the treatment arm: the rehabilitation programme plus standard care, or the control arm: standard care alone. The treatment arm will consist of an 8 week rehabilitation programme, supervised at weekly clinics by a physiotherapist and dietician. To avoid the control group trying to mimic these interventions, they will be offered the treatment at the end of the 8 weeks.
Measurements will be made for both groups and compared at baseline (week 0), midpoint (week 5) and endpoint (week 9). Recommendations for a larger UK wide trial will be made from the findings of this study.REC name
West of Scotland REC 4
REC reference
17/WS/0226
Date of REC Opinion
10 Nov 2017
REC opinion
Favourable Opinion