Exercise and Nutritional Rehabilitation in Patients With Cancer (ENeRgy)

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Diet Modification; Advanced Cancer; Cachexia; Cancer
• Intervention / Treatment: Dietary supplement: ProSure; Behavioral: Physical Exercise

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XR
    • University of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of advanced cancer (defined as metastatic or locally advanced cancer not amenable to curative treatment).
2. Outpatient
3. ≥18years
4. Karnofsky score ≥ 60
5. Prognosis greater than 3 months
6. Able to complete trial based assessments
7. Under care of community services at Marie Curie or St Columba's Hospices
8. Ability to comply with trial protocol
9. Ability to provide and have capacity to consent
10. Agree to attend trial centre for trial related activity (St Columba's Hospice)

Exclusion Criteria:

1. Undergoing anti-cancer therapy (hormonal treatment or bisphosphonates permitted)
2. Using enteral nutrition (NG or similar) or parenteral nutrition
3. Co-enrolment in drug trials
4. Inability to swallow

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rehabilitation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Rehabilitation programme	Compliance with treatment and trial procedures	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient quality of life	Measured by EORTC QLQ-C15-PAL questionnaire	8 weeks
Carer quality of life	Measured by CQOLC questionnaire	8 weeks
Change in physical function	Mean daily step count, measured by Physical Activity Meter over 5 days	8 weeks
Change in physical function	Measured by two-minute walk test (metres/feet covered)	8 weeks
Change in physical function	Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint	8 weeks
Change in physical function	Measured by timed up-and-go test (Seconds)	8 weeks
Change in physical function	Measured by Life Space Assessment scores	8 weeks
Sleep quality	Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)	8 weeks
Nutritional status	Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)	8 weeks
Nutritional status	Measured by PG-SGA nutritional assessment (PG-SGA point score)	8 weeks
Contamination in the control group	Measured by dietary intake using 24 hour recall (patient diary entries)	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	8 weeks

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian; Marie Curie Hospice, Belfast; Accord Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): July 3, 2019

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Emaciation; Weight Loss; Cachexia
• Other Study ID Numbers: AC17085

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No