ENeRgy

Trial Name

ENeRgy - Exercise and Nutritional Rehabilitation in patients with cancer.

Description

A randomised, phase II, open-label trial of an Exercise and Nutrition based Rehabilitation programme (ENeRgy) versus standard care, in patients with cancer. The study will investigate whether an exercise and nutrition based rehabilitation programme is feasible in a hospice setting and improves physical function, nutritional status and quality of life, in patients with advanced cancer.

Objectives

Primary Objective:

• The primary aim of this trial is to investigate the feasibility of the treatment (exercise and nutrition based rehabilitation programme) by assessing compliance with treatment and trial procedures.

Secondary Objectives:

• To examine the recruitment rate.
• To assess contamination rate in the control group with respect to any of the treatment.
• Does the treatment affect physical function?
• Does the treatment affect nutrition?
• Does the treatment affect quality of life for patients and/or carers?
• Does the treatment affect health economic parameters?
  

Design

The trial is a single centre, randomised (1:1), unblinded, feasibility trial of an exercise and nutrition based rehabilitation programme (treatment) versus standard care (control), in patients with advanced cancer. Time scales proposed include 4 months trial set up, 13 months recruitment, 3 months for follow up and 4 months for analysis and publication of the final trial report.

Population

Forty patients will be recruited (20 in each arm).

Contacts

Sponsor: University of Edinburgh

Chief Investigator: Dr Barry Laird

Trial Manager: Lucy Norris