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Clinical Trials/NCT04406662
NCT04406662
Recruiting
N/A

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

University of Edinburgh1 site in 1 country600 target enrollmentJuly 15, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cachexia; Cancer
Sponsor
University of Edinburgh
Enrollment
600
Locations
1
Primary Endpoint
Association between inflammatory cytokines and clinical parameters in incurable cancer
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2020
End Date
August 8, 2029
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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