An interventional study of ProSure and Physical Exercise in Cachexia; Cancer, Diet Modification and Physical Activity, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by University of Edinburgh · Not applicable, Interventional, and Supportive care
Among 23 studies in Cachexia with a site in United Kingdom — 7 open to participants now, 7 under way, 2 of them phase 3. Cachexia · United Kingdom.
Among the 23 studies in Cachexia with a site in United Kingdom, this one is the 13th largest by enrollment of the 16 interventional ones that give a count, is one of 3 that started in 2018, is one of 6 with no phase, and was the 12th registered.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
Browse Cachexia studies →7 of the 23 studies in Cachexia with a site in United Kingdom are open now. Recruiting first, the newest first:
Queen's University, Belfast · Sites in United Kingdom
CatalYm GmbH · Sites in United Kingdom, United States, Bulgaria and 11 more countries
Pfizer · Sites in United Kingdom, United States, Australia and 18 more countries
University of Cambridge · Sites in United Kingdom
University of Edinburgh · Sites in United Kingdom
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 56 Cachexia studies recruiting now, 32 (57%) set no upper age limit and 15 (27%) stop at 75 or younger; 8 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 4
First in 2007; this study’s year is marked. 3 started in 2018.
This study's enrollment of 45 is below the median of 74 across 226 interventional studies indexed under Cachexia.
Median enrollment 65 across the 16 interventional studies, 200 across the 7 observational. Of the 14 that completed or were terminated, 4 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 23 have an industry lead sponsor. The 10 most frequent:
University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
University of Edinburgh has 4 studies filed under Cachexia — fewer than ten, so there is no comparison to draw.
2 of the studies in Cachexia with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07107087Queen's University, BelfastA Multimodal Integrated Intervention for Kidney Cachexia | 2027-08-01 |
| NCT06112964University of CambridgeNeurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG) | 2027-11 |
Among the 23 studies in Cachexia with a site in United Kingdom, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care
Dietary Supplement: ProSure · Behavioral: Physical Exercise
Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme
Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition
Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week
Feasibility of Rehabilitation programme
Compliance with treatment and trial procedures
Time frame: 8 weeks
Patient quality of life
Measured by EORTC QLQ-C15-PAL questionnaire
Time frame: 8 weeks
Carer quality of life
Measured by CQOLC questionnaire
Time frame: 8 weeks
Change in physical function
Mean daily step count, measured by Physical Activity Meter over 5 days
Time frame: 8 weeks
Change in physical function
Measured by two-minute walk test (metres/feet covered)
Time frame: 8 weeks
Change in physical function
Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint
Time frame: 8 weeks
Change in physical function
Measured by timed up-and-go test (Seconds)
Time frame: 8 weeks
Change in physical function
Measured by Life Space Assessment scores
Time frame: 8 weeks
Sleep quality
Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)
Time frame: 8 weeks
Nutritional status
Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)
Time frame: 8 weeks
Nutritional status
Measured by PG-SGA nutritional assessment (PG-SGA point score)
Time frame: 8 weeks
Contamination in the control group
Measured by dietary intake using 24 hour recall (patient diary entries)
Time frame: 8 weeks
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
Time frame: 8 weeks
Ran from Jan 2018 to primary completion in Apr 2019, 14 months.
Of 75 non-industry interventional studies with no phase under Cachexia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's 14 months is below that.
Counting every sponsor, half of 77 studies reached it within 19 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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