Exercise and Nutritional Rehabilitation in Patients With Cancer
NCT ID: NCT03316157
Last Updated: 2020-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2018-01-30
2019-07-03
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Rehabilitation
Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care
ProSure
Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition
Physical Exercise
Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week
Waiting list Control
Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme
No interventions assigned to this group
Interventions
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ProSure
Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition
Physical Exercise
Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week
Eligibility Criteria
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Inclusion Criteria
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
2. Using enteral nutrition (NG or similar) or parenteral nutrition
3. Co-enrolment in drug trials
4. Inability to swallow
18 Years
ALL
Yes
Sponsors
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Marie Curie Hospice, Belfast
OTHER
Accord Clinical Research
OTHER
NHS Lothian
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
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Locations
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University of Edinburgh
Edinburgh, , United Kingdom
Countries
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Other Identifiers
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AC17085
Identifier Type: -
Identifier Source: org_study_id
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