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Completed

NCT Number: NCT03316157

Exercise and Nutritional Rehabilitation in Patients With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Edinburgh

Edinburgh, EH4 2XR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ProSure

Dietary Supplement

Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition

Physical exercise

Behavioral

Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week

Primary outcomes

  1. Feasibility of Rehabilitation programme

    Time frame: 8 weeks

    Compliance with treatment and trial procedures

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Accord Clinical Research
  • Marie Curie Hospice, Belfast
  • NHS Lothian

Registry information

Official study 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

Acronym: ENeRgy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2017
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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