Exercise and Nutritional Rehabilitation in Patients With Cancer (ENeRgy)
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|ClinicalTrials.gov Identifier: NCT03316157|
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : March 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cachexia; Cancer Diet Modification Physical Activity Advanced Cancer||Dietary Supplement: ProSure Behavioral: Physical Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised (1:1) unblinded feasibility trial of a rehabilitation programme (exercise and nutrition) versus waiting list control, in patients with advanced cancer|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Actual Study Start Date :||January 30, 2018|
|Actual Primary Completion Date :||April 24, 2019|
|Actual Study Completion Date :||July 3, 2019|
Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care
Dietary Supplement: ProSure
Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition
Behavioral: Physical Exercise
Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week
No Intervention: Waiting list Control
Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme
- Feasibility of Rehabilitation programme [ Time Frame: 8 weeks ]Compliance with treatment and trial procedures
- Patient quality of life [ Time Frame: 8 weeks ]Measured by EORTC QLQ-C15-PAL questionnaire
- Carer quality of life [ Time Frame: 8 weeks ]Measured by CQOLC questionnaire
- Change in physical function [ Time Frame: 8 weeks ]Mean daily step count, measured by Physical Activity Meter over 5 days
- Change in physical function [ Time Frame: 8 weeks ]Measured by two-minute walk test (metres/feet covered)
- Change in physical function [ Time Frame: 8 weeks ]Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint
- Change in physical function [ Time Frame: 8 weeks ]Measured by timed up-and-go test (Seconds)
- Change in physical function [ Time Frame: 8 weeks ]Measured by Life Space Assessment scores
- Sleep quality [ Time Frame: 8 weeks ]Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)
- Nutritional status [ Time Frame: 8 weeks ]Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)
- Nutritional status [ Time Frame: 8 weeks ]Measured by PG-SGA nutritional assessment (PG-SGA point score)
- Contamination in the control group [ Time Frame: 8 weeks ]Measured by dietary intake using 24 hour recall (patient diary entries)
- Contamination in the control group [ Time Frame: 8 weeks ]Measured by change in measures of physical function (see outcomes 4-8) in control group from baseline measurement to endpoint
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316157
|University of Edinburgh|
|Edinburgh, United Kingdom, EH4 2XR|