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NCT04285242 Clinical Trial

Metabolic and Immunological Phenotyping in Patients With Cancer

Cancer Clinical Trial

— MIPPaC  

Official title:
Metabolic and Immunological Phenotyping in Patients With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04285242
Other study ID # MIPPaC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 7, 2021
Est. completion date June 1, 2024

Study information
Verified date February 2024
Source Cambridge University Hospitals NHS Foundation Trust
Contact Early Phase Team Cambridge Cancer Trials Unit - Cancer Theme
Phone 01223216083
Email cuh.cctuep@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Observational assessments
Clinical assessments

Locations
Country Name City State
United Kingdom Addenbrooke's Hospital, Cambridge University Hospitals Foundation Trust, Cambridge Cambridgeshire
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge England

Sponsors (1)
Lead Sponsor Collaborator
CCTU- Cancer Theme

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum cortisol level Blood serum cortisol levels in weight losing and weight stable patients at baseline and Day 2 Change from baseline serum cortisol level at Day 2
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