University of Edinburgh
Edinburgh, EH4 2XR, United Kingdom
NCT Number: NCT03316157
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".
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 will be the primary outcome measure including rates of recruitment and compliance. Secondary outcome 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 minimise contamination the control group will be offered the treatment at the end of the 8 weeks (waiting list control).
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Edinburgh, EH4 2XR, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition
Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week
Time frame: 8 weeks
Compliance with treatment and trial procedures
Time frame: 8 weeks
Measured by EORTC QLQ-C15-PAL questionnaire
Time frame: 8 weeks
Measured by CQOLC questionnaire
Time frame: 8 weeks
Mean daily step count, measured by Physical Activity Meter over 5 days
Time frame: 8 weeks
Measured by two-minute walk test (metres/feet covered)
Time frame: 8 weeks
Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint
Time frame: 8 weeks
Measured by timed up-and-go test (Seconds)
Time frame: 8 weeks
Measured by Life Space Assessment scores
Time frame: 8 weeks
Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)
Time frame: 8 weeks
Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)
Time frame: 8 weeks
Measured by PG-SGA nutritional assessment (PG-SGA point score)
Time frame: 8 weeks
Measured by dietary intake using 24 hour recall (patient diary entries)
Time frame: 8 weeks
Measured by change in measures of physical function (see outcomes 4-8) in control group from baseline measurement to endpoint
University of Edinburgh
Other
Exercise and Nutritional Rehabilitation in Patients With Cancer, Randomised (1:1) Unblinded Feasibility Trial of a Rehabilitation Programme (Exercise and Nutrition) Versus Waiting List Control, in Patients With Advanced Cancer
Acronym: ENeRgy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04131426
Behavior, Body Weight
Rochester, New York, United States
View Trial DetailsNCT04406662
Advanced Cancer, Body Weight
Edinburgh, United Kingdom
View Trial DetailsNCT03743051
Body Weight, Body Weight Changes
Tucson, Arizona, United States
View Trial DetailsNCT03743064
Body Weight, Body Weight Changes
Tucson, Arizona, United States
View Trial Details