Routine Evaluation of People Living With Cancer

Quality of Life Clinical Trial

— REVOLUTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406662
• Other study ID #: AC19154
• Status: Recruiting
• Start date: July 15, 2020
• Est. completion date: August 8, 2029

Study information

• Verified date: April 2021
• Source: University of Edinburgh
• Contact: Barry JA Laird, MBCHB MD
• Phone: 01316518611
• Email: barry.laird[@]ed.ac.uk
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Cachexia
• Cachexia; Cancer
• Quality of Life

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