Cachexia; CancerENeRgyNCT03316157
Exercise and Nutritional Rehabilitation in Patients With Cancer
A study testing ProSure and Physical Exercise in people with Cachexia; Cancer and Diet Modification, run by University of Edinburgh at 1 site in United Kingdom.
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". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cachexia; Cancer, Diet Modification, Physical Activity
- What is being tested?
- ProSure and Physical Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2018to 3 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced cancer (defined as metastatic or locally advanced cancer not amenable to curative treatment).
- Outpatient
- ≥18years
- Karnofsky score ≥ 60
- Prognosis greater than 3 months
- Able to complete trial based assessments
Show all 10Show fewer
- Under care of community services at Marie Curie or St Columba's Hospices
- Ability to comply with trial protocol
- Ability to provide and have capacity to consent
- Agree to attend trial centre for trial related activity (St Columba's Hospice)
Who cannot join
- Undergoing anti-cancer therapy (hormonal treatment or bisphosphonates permitted)
- Using enteral nutrition (NG or similar) or parenteral nutrition
- Co-enrolment in drug trials
- Inability to swallow
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Being tested
- ProSure, Physical Exercise
- Medical subject headings
- Cachexia, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSureDietary supplement
Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition
Physical ExerciseBehavioural
Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation | Experimental | Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care Receives: Dietary Supplement: ProSure; Behavioral: Physical Exercise |
| Waiting list Control | No intervention | Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Rehabilitation programme
Compliance with treatment and trial procedures
Measured: 8 weeks
Secondary outcomes (12)
Patient quality of life
Measured by EORTC QLQ-C15-PAL questionnaire
Measured: 8 weeks
Carer quality of life
Measured by CQOLC questionnaire
Measured: 8 weeks
Change in physical function
Mean daily step count, measured by Physical Activity Meter over 5 days
Measured: 8 weeks
Change in physical function
Measured by two-minute walk test (metres/feet covered)
Measured: 8 weeks
Change in physical function
Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint
Measured: 8 weeks
Change in physical function
Measured by timed up-and-go test (Seconds)
Measured: 8 weeks
Change in physical function
Measured by Life Space Assessment scores
Measured: 8 weeks
Sleep quality
Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)
Measured: 8 weeks
Nutritional status
Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)
Measured: 8 weeks
Nutritional status
Measured by PG-SGA nutritional assessment (PG-SGA point score)
Measured: 8 weeks
Contamination in the control group
Measured by dietary intake using 24 hour recall (patient diary entries)
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start30 Jan 2018
- Primary completion24 Apr 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia; CancerStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised (1:1) unblinded feasibility trial of a rehabilitation programme (exercise and nutrition) versus waiting list control, in patients with advanced cancer
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Marie Curie Hospice, Belfast, Accord Clinical Research, NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316157
- Sponsor's protocol ID
- AC17085
- Acronym
- ENeRgy
- Status last verified
- Mar 2020
- First submitted
- 22 Sep 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03316157
- Acronym / sponsor ID
- ENeRgy / AC17085
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Marie Curie Hospice, Belfast, Accord Clinical Research, NHS Lothian
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised (1:1) unblinded feasibility trial of a rehabilitation programme (exercise and nutrition) versus waiting list control, in patients with advanced cancer
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation | Experimental | Dietary Supplement: ProSure, Behavioral: Physical ExerciseAdvanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care |
| Waiting list Control | No intervention | –Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of advanced cancer (defined as metastatic or locally advanced cancer not amenable to curative treatment).
- Outpatient
- ≥18years
- Karnofsky score ≥ 60
- Prognosis greater than 3 months
Key exclusion criteria (4 listed)
- Undergoing anti-cancer therapy (hormonal treatment or bisphosphonates permitted)
- Using enteral nutrition (NG or similar) or parenteral nutrition
- Co-enrolment in drug trials
- Inability to swallow
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProSurePatients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition | Dietary supplement | Rehabilitation |
| Physical ExercisePatients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week | Behavioural | Rehabilitation |
Primary outcome
Feasibility of Rehabilitation programme
Time frame: 8 weeks
Compliance with treatment and trial procedures
12 secondary outcomes
Patient quality of life
Time frame: 8 weeks
Carer quality of life
Time frame: 8 weeks
Change in physical function
Time frame: 8 weeks
Change in physical function
Time frame: 8 weeks
Change in physical function
Time frame: 8 weeks
Change in physical function
Time frame: 8 weeks
Change in physical function
Time frame: 8 weeks
Sleep quality
Time frame: 8 weeks
Nutritional status
Time frame: 8 weeks
Nutritional status
Time frame: 8 weeks
Contamination in the control group
Time frame: 8 weeks
Contamination in the control group
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProSure and Physical Exercise in people with Cachexia; Cancer and Diet Modification, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Rehabilitation programme (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.