Clinical trial NCT03316157: Exercise and Nutritional Rehabilitation in Patients With Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cachexia; Cancer
Diet Modification
Physical Activity
Advanced Cancer
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Marie Curie Hospice, Belfast
name: Accord Clinical Research
name: NHS Lothian
First posted: 2017-10-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of Rehabilitation programme
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient quality of life
timeFrame: 8 weeks
measure: Carer quality of life
timeFrame: 8 weeks
measure: Change in physical function
timeFrame: 8 weeks
measure: Change in physical function
timeFrame: 8 weeks
measure: Change in physical function
timeFrame: 8 weeks
measure: Change in physical function
timeFrame: 8 weeks
measure: Change in physical function
timeFrame: 8 weeks
measure: Sleep quality
timeFrame: 8 weeks
measure: Nutritional status
timeFrame: 8 weeks
measure: Nutritional status
timeFrame: 8 weeks
measure: Contamination in the control group
timeFrame: 8 weeks
measure: Contamination in the control group
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
Study officials:
References: