Exercise and Nutritional Rehabilitation in Patients With Cancer

Not Applicable

Completed

• Conditions: Diet Modification; Advanced Cancer; Cachexia; Cancer; Physical Activity
• Interventions: Dietary Supplement: ProSure; Behavioral: Physical Exercise

• Registration Number: NCT03316157
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-20
• Study Start: 2018-01-30
• Primary Completion: 2019-04-24
• Study Completion: 2019-07-03
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation	ProSure	Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care
Rehabilitation	Physical Exercise	Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care

Primary Outcome Measures

Name	Time	Method
Feasibility of Rehabilitation programme	8 weeks	Compliance with treatment and trial procedures

Secondary Outcome Measures

Name	Time	Method
Carer quality of life	8 weeks	Measured by CQOLC questionnaire
Sleep quality	8 weeks	Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)
Patient quality of life	8 weeks	Measured by EORTC QLQ-C15-PAL questionnaire
Change in physical function	8 weeks	Measured by Life Space Assessment scores
Nutritional status	8 weeks	Measured by PG-SGA nutritional assessment (PG-SGA point score)
Contamination in the control group	8 weeks	Measured by change in measures of physical function (see outcomes 4-8) in control group from baseline measurement to endpoint

Trial Locations

Locations (1)

University of Edinburgh; 🇬🇧 Edinburgh, United Kingdom