An interventional study of ProSure and Physical Exercise in Cachexia; Cancer, Diet Modification and Physical Activity, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by University of Edinburgh · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care
Dietary Supplement: ProSure · Behavioral: Physical Exercise
Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme
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
Feasibility of Rehabilitation programme
Compliance with treatment and trial procedures
Time frame: 8 weeks
Patient quality of life
Measured by EORTC QLQ-C15-PAL questionnaire
Time frame: 8 weeks
Carer quality of life
Measured by CQOLC questionnaire
Time frame: 8 weeks
Change in physical function
Mean daily step count, measured by Physical Activity Meter over 5 days
Time frame: 8 weeks
Change in physical function
Measured by two-minute walk test (metres/feet covered)
Time frame: 8 weeks
Change in physical function
Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint
Time frame: 8 weeks
Change in physical function
Measured by timed up-and-go test (Seconds)
Time frame: 8 weeks
Change in physical function
Measured by Life Space Assessment scores
Time frame: 8 weeks
Sleep quality
Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)
Time frame: 8 weeks
Nutritional status
Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)
Time frame: 8 weeks
Nutritional status
Measured by PG-SGA nutritional assessment (PG-SGA point score)
Time frame: 8 weeks
Contamination in the control group
Measured by dietary intake using 24 hour recall (patient diary entries)
Time frame: 8 weeks
Contamination in the control group
Measured by change in measures of physical function (see outcomes 4-8) in control group from baseline measurement to endpoint
Time frame: 8 weeks
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Edinburgh