Clinical trial NCT04406662: Routine Evaluation of People Living With Cancer
Official title: Routine Evaluation of People Living With Cancer - Body Composition, Physical Function, Systemic Inflammatory Response, Quality of Life and Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2020-05-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living with incurable cancer recruited from oncology and palliative care services in the UK

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Association between inflammatory cytokines and clinical parameters in incurable cancer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: St Columba's Hospice
Study officials:
affiliation: St Columba's Hospice/ University of Edinburgh
name: Barry JA Laird, MBCHB MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.