Exercise and Nutritional Rehabilitation in Patients With Cancer (ENeRgy)

University of Edinburgh

Status: Completed

Conditions: Advanced Cancer; Physical Activity; Cachexia; Cancer; Diet Modification

Treatments: Behavioral: Physical Exercise; Dietary Supplement: ProSure

Study type: Interventional

Funder types: Other

Identifiers

NCT03316157

AC17085

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Rehabilitation

Experimental group

Description:

Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care

Treatment:

Behavioral: Physical Exercise

Dietary Supplement: ProSure

Waiting list Control

No Intervention group

Description:

Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme