Metabolic and Immunological Phenotyping in Patients With Cancer (MIPPaC)

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Non-Hematologic Malignancy
• Intervention / Treatment: Other: Observational assessments

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Early Phase Team Cambridge Cancer Trials Unit - Cancer Theme; Phone Number: 01223216083; Email: cuh.cctuep@nhs.net
• Study Contact Backup: Name: Cambridge Cancer Trials Centre, Coordination Team; Phone Number: 01223216083; Email: cuh.cctu-ct@nhs.net

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Recruiting
      • Addenbrooke's Hospital, Cambridge University Hospitals Foundation Trust,
  • England
    • Cambridge, England, United Kingdom, CB2 2QQ
      • Recruiting
      • Cambridge University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Male and Female participants who have cancer or are healthy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers - Group A; Assessments and observations for up to 2 days with one overnight hospital stay.	Other: Observational assessments; Clinical assessments
Healthy Volunteers - Group B; Assessments and observations for up to 2 days.	Other: Observational assessments; Clinical assessments
Participants with Cancer - Group A; Assessments and observations for up to 40 days with one overnight hospital stay.	Other: Observational assessments; Clinical assessments
Participants with Cancer - Group B; Assessments and observations for up to 40 days, with most assessments and observations being optional and no overnight hospital stay.	Other: Observational assessments; Clinical assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CCTU- Cancer Theme
• Investigators: Principal Investigator: Claire Connell, University of Cambridge

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Non-haematological
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MIPPaC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No