Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise and Nutritional Rehabilitation in Patients With Cancer (ENeRgy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03316157
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : March 11, 2020
Sponsor:
Collaborators:
Marie Curie Hospice, Belfast
Accord Clinical Research
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Feasibility of Rehabilitation programme [ Time Frame: 8 weeks ]
    Compliance with treatment and trial procedures


Secondary Outcome Measures :
  1. Patient quality of life [ Time Frame: 8 weeks ]
    Measured by EORTC QLQ-C15-PAL questionnaire

  2. Carer quality of life [ Time Frame: 8 weeks ]
    Measured by CQOLC questionnaire

  3. Change in physical function [ Time Frame: 8 weeks ]
    Mean daily step count, measured by Physical Activity Meter over 5 days

  4. Change in physical function [ Time Frame: 8 weeks ]
    Measured by two-minute walk test (metres/feet covered)

  5. Change in physical function [ Time Frame: 8 weeks ]
    Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint

  6. Change in physical function [ Time Frame: 8 weeks ]
    Measured by timed up-and-go test (Seconds)

  7. Change in physical function [ Time Frame: 8 weeks ]
    Measured by Life Space Assessment scores

  8. Sleep quality [ Time Frame: 8 weeks ]
    Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)

  9. Nutritional status [ Time Frame: 8 weeks ]
    Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)

  10. Nutritional status [ Time Frame: 8 weeks ]
    Measured by PG-SGA nutritional assessment (PG-SGA point score)

  11. Contamination in the control group [ Time Frame: 8 weeks ]
    Measured by dietary intake using 24 hour recall (patient diary entries)

  12. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United Kingdom
University of Edinburgh
Edinburgh, United Kingdom, EH4 2XR
Sponsors and Collaborators
University of Edinburgh
Marie Curie Hospice, Belfast
Accord Clinical Research
NHS Lothian
Layout table for additonal information
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03316157    
Other Study ID Numbers: AC17085
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight