Cachexia; CancerREVOLUTIONNCT04406662
Routine Evaluation of People Living With Cancer
An observational study of Cachexia; Cancer and Advanced Cancer, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
People with incurable cancer often have complex individual needs, however there are several common themes encountered when considering this group. As cancer progresses there are series of interactions between the tumour and the patient, producing both local and systemic effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia; Cancer, Advanced Cancer, Quality of Life
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2020to 8 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: People living with incurable cancer recruited from oncology and palliative care services in the UK
Who may be able to join
- Patients with incurable cancer (metastatic cancer (Clinical, histological, cytological or radiological evidence) or receiving anti-cancer therapy with palliative intent).
- Aged 18-years and over
- Written informed consent
Who cannot join
- Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would increase the risk of complication for the participant and/or investigator.
- Participants will not be able to take part in bio-impedance analysis if they have a pacemaker or implantable cardiac defibrillator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St Columba's Hospice
Edinburgh, EH53RW
Rebekah Patton, 01315511381, rpatton@stcolumbashospice.org.uk
About this study
Official title: Routine Evaluation of People Living With Cancer - Body Composition, Physical Function, Systemic Inflammatory Response, Quality of Life and Symptoms
People with incurable cancer often have complex individual needs, however there are several common themes encountered when considering this group.
As cancer progresses there are series of interactions between the tumour and the patient, producing both local and systemic effects. This altered state of illness can have multiple ill effects including weight loss, fatigue, increased symptom burden and reduction in physical function which all contribute to a reduced quality of life.
Read more
These areas are often studied in isolation, giving an incomplete picture. A detailed, holistic characterisation of this group of people does not exist.
A robust characterisation of people with incurable cancer will allow identification and prioritisation of future research and has the potential to inform new therapeutics and provide justification for treatments.
This study aims to collect information about symptoms and quality of life, weight loss and body composition, physical activity and the body's immune response to cancer.
Participants with incurable cancer will be recruited to the study from oncology and palliative medicine services in the UK. Participants will answer questionnaires about quality of life and symptoms, have bloods taken for inflammatory marker and cytokine analysis and have their body composition measured by a variety of methods.
- Conditions
- Cachexia; Cancer, Advanced Cancer, Quality of Life
- Keywords
- cancer, advanced cancer, incurable cancer, body composition, physical function, symptoms, cachexia, quality of life, systemic inflammatory response, palliative medicine
- Medical subject headings
- Cachexia, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between inflammatory cytokines and clinical parameters in incurable cancer
Correlation of serum levels of inflammatory cytokines with clinical parameters including skeletal muscle mass, symptom based scores and physical activity as measured by actigraphy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start15 Jul 2020
- Primary completion8 Aug 2029 (estimated)
- Study completion8 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Barry JA Laird, MBCHB MD, Principal investigator, St Columba's Hospice/ University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406662
- Sponsor's protocol ID
- AC19154
- Acronym
- REVOLUTION
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2020
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Paval DR, Patton R, McDonald J, Skipworth RJE, Gallagher IJ, Laird BJ; Caledonian Cachexia Collaborative. A systematic review examining the relationship between cytokines and cachexia in incurable cancer. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):824-838. doi: 10.1002/jcsm.12912. Epub 2022 Jan 25.
PubMed 35080147
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Evaluation of People Living With Cancer - Body Composition, Physical Function, Systemic Inflammatory Response, Quality of Life and Symptoms
- ClinicalTrials.gov ID
- NCT04406662
- Acronym / sponsor ID
- REVOLUTION / AC19154
- Conditions
- Cachexia; Cancer, Advanced Cancer, Quality of Life
- Keywords
- cancer, advanced cancer, incurable cancer, body composition, physical function, symptoms, cachexia, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 8 Aug 2029 (estimated)
- Study completion
- 8 Aug 2029 (estimated)
- First posted
- 28 May 2020 (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.
People with incurable cancer often have complex individual needs, however there are several common themes encountered when considering this group.
As cancer progresses there are series of interactions between the tumour and the patient, producing both local and systemic effects. This altered state of illness can have multiple ill effects including weight loss, fatigue, increased symptom burden and reduction in physical function which all contribute to a reduced quality of life.
These areas are often studied in isolation, giving an incomplete picture. A detailed, holistic characterisation of this group of people does not exist.
A robust characterisation of people with incurable cancer will allow identification and prioritisation of future research and has the potential to inform new therapeutics and provide justification for treatments.
This study aims to collect information about symptoms and quality of life, weight loss and body composition, physical activity and the body's immune response to cancer.
Participants with incurable cancer will be recruited to the study from oncology and palliative medicine services in the UK. Participants will answer questionnaires about quality of life and symptoms, have bloods taken for inflammatory marker and cytokine analysis and have their body composition measured by a variety of methods.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with incurable cancer recruited from oncology and palliative care services in the UK
Key inclusion criteria (3 listed)
- Patients with incurable cancer (metastatic cancer (Clinical, histological, cytological or radiological evidence) or receiving anti-cancer therapy with palliative intent).
- Aged 18-years and over
- Written informed consent
Key exclusion criteria (2 listed)
- Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would increase the risk of complication for the participant and/or investigator.
- Participants will not be able to take part in bio-impedance analysis if they have a pacemaker or implantable cardiac defibrillator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between inflammatory cytokines and clinical parameters in incurable cancer
Time frame: 2 years
Correlation of serum levels of inflammatory cytokines with clinical parameters including skeletal muscle mass, symptom based scores and physical activity as measured by actigraphy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 35080147Paval DR, Patton R, McDonald J, Skipworth RJE, Gallagher IJ, Laird BJ; Caledonian Cachexia Collaborative. A systematic review examining the relationship between cytokines and cachexia in incurable cancer. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):824-838. doi: 10.1002/jcsm.12912. Epub 2022 Jan 25.
- Individual participant dataSharing planned: Yes
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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.
Barry JA Laird, MBCHB MD principal investigator
St Columba's Hospice/ University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia; Cancer and Advanced Cancer, 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barry JA Laird, MBCHB MD (01316518611, barry.laird@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between inflammatory cytokines and clinical parameters in incurable cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406662, which also lists 1 linked publication.
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 7 Jul 2026.