Advanced Cancer, Cachexia; Cancer, Diet Modification, Physical Activity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProSure
Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition
BEHAVIORALPhysical Exercise
Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week
Sponsors
Marie Curie Hospice, Belfast
Accord Clinical Research
NHS Lothian
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Rehabilitation programme | 8 weeks | Compliance with treatment and trial procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carer quality of life | 8 weeks | Measured by CQOLC questionnaire |
| Change in physical function | 8 weeks | Mean daily step count, measured by Physical Activity Meter over 5 days |
| Patient quality of life | 8 weeks | Measured by EORTC QLQ-C15-PAL questionnaire |
| Nutritional status | 8 weeks | Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2) |
| Contamination in the control group | 8 weeks | Measured by dietary intake using 24 hour recall (patient diary entries) |
| Sleep quality | 8 weeks | Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake) |
Countries
United Kingdom
Outcome results
None listed