Metabolic and Immunological Phenotyping in Patients With Cancer

Recruiting

• Conditions: Non-Hematologic Malignancy; Cancer

• Registration Number: NCT04285242
• Lead Sponsor: CCTU- Cancer Theme

Brief Summary

An observational study to investigate cachexia in participants with non-haematological cancer.

Detailed Description

A single-centre, non-randomised, observational study. This study will investigate the systemic metabolic and immunological changes that occur in cachexia. The aim is to better understand the mechanism(s) underlying weight loss in people with non-haematological cancer. This will help to facilitate future research to generate treatments to reverse weight loss and improve outcomes.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Study Start: 2021-12-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Have given written informed consent to participate
• Be aged 18 years or over at the time of signing the informed consent form
• Have a histological or cytological diagnosis of a non-haematological cancer
• Are willing and able to comply with study procedures and visits

Exclusion Criteria

• Active infection, as determined by the investigator based on clinical symptoms and / or fever and / or requirement for antibiotics
• Current treatment with chemotherapy, oral steroids or other immunosuppressive drugs (within 7 days of baseline investigations or during the study phase)
• Significant acute, chronic or psychiatric condition or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the study.
• Intolerance to dairy products
• Women, who are pregnant, plan to become pregnant or are lactating

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum cortisol level	Change from baseline serum cortisol level at Day 2	Blood serum cortisol levels in weight losing and weight stable patients at baseline and Day 2

Trial Locations

Locations (2)

Addenbrooke's Hospital, Cambridge University Hospitals Foundation Trust,; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, England, United Kingdom