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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Non-Hematologic Malignancy

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