Metabolic and Immunological Phenotyping in Patients With Cancer (MIPPaC)

CCTU- Cancer Theme

Status: Enrolling

Conditions: Cancer; Non-Hematologic Malignancy

Treatments: Other: Observational assessments

Study type: Observational

Funder types: Other

Identifiers

NCT04285242

MIPPaC

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Participants with Cancer - Group A

Description:

Assessments and observations for up to 40 days with one overnight hospital stay.

Treatment:

Other: Observational assessments

Healthy Volunteers - Group A

Description:

Assessments and observations for up to 2 days with one overnight hospital stay.

Treatment:

Other: Observational assessments

Healthy Volunteers - Group B

Description:

Assessments and observations for up to 2 days.

Treatment:

Other: Observational assessments

Participants with Cancer - Group B

Description:

Assessments and observations for up to 40 days, with most assessments and observations being optional and no overnight hospital stay.

Treatment:

Other: Observational assessments