Exercise and Nutritional Rehabilitation in Patients With Cancer

Physical Activity Clinical Trial

— ENeRgy  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316157
• Other study ID #: AC17085
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: July 3, 2019

Study information

• Verified date: March 2020
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 3, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Cachexia
• Cachexia; Cancer
• Diet Modification
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh	Edinburgh

Sponsors (4)

Lead Sponsor	Collaborator
University of Edinburgh	Accord Clinical Research, Marie Curie Hospice, Belfast, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Rehabilitation programme	Compliance with treatment and trial procedures	8 weeks
Secondary	Patient quality of life	Measured by EORTC QLQ-C15-PAL questionnaire	8 weeks
Secondary	Carer quality of life	Measured by CQOLC questionnaire	8 weeks
Secondary	Change in physical function	Mean daily step count, measured by Physical Activity Meter over 5 days	8 weeks
Secondary	Change in physical function	Measured by two-minute walk test (metres/feet covered)	8 weeks
Secondary	Change in physical function	Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint	8 weeks
Secondary	Change in physical function	Measured by timed up-and-go test (Seconds)	8 weeks
Secondary	Change in physical function	Measured by Life Space Assessment scores	8 weeks
Secondary	Sleep quality	Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)	8 weeks
Secondary	Nutritional status	Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)	8 weeks
Secondary	Nutritional status	Measured by PG-SGA nutritional assessment (PG-SGA point score)	8 weeks
Secondary	Contamination in the control group	Measured by dietary intake using 24 hour recall (patient diary entries)	8 weeks
Secondary	Contamination in the control group	Measured by change in measures of physical function (see outcomes 4-8) in control group from baseline measurement to endpoint	8 weeks