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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04406662
Other study ID # AC19154
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date August 8, 2029

Study information

Verified date May 2024
Source University of Edinburgh
Contact Barry JA Laird, MBCHB MD
Phone 01316518611
Email barry.laird@ed.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date August 8, 2029
Est. primary completion date August 8, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom St Columba's Hospice Edinburgh

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years
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