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Recruiting NCT04406662

Routine Evaluation of People Living With Cancer

Observational Cachexia; Cancer Advanced Cancer Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cachexia; Cancer, Advanced Cancer, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Routine Evaluation of People Living With Cancer - Body Composition, Physical Function, Systemic Inflammatory Response, Quality of Life and Symptoms

Overview

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.

Primary outcome measures

  • Association between inflammatory cytokines and clinical parameters in incurable cancer [Time frame: 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United Kingdom · 1 center
  • St Columba's Hospice — Edinburgh

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. PMID 35080147

Identifiers

NCT: NCT04406662 · AC19154

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗