The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients

University of Copenhagen

Status: Completed

Conditions: Pancreas Cancer; Colorectal Cancer

Treatments: Diagnostic Test: Bio Impedance Spectroscopy (BIS)

Study type: Observational

Funder types: Other

Identifiers

NCT04528745

H-20000245

Details and patient eligibility

About

An observational study of the relationship between fat free mass and toxicity of cytostatics in cancer patients, at the department of Clinical Oncology at Zealand University Hospital, Roskilde, Denmark. Fat free mass will be measured by bio impedance spectroscopy and data on toxicity will be obtained from medical records and interviews/questionnaires with the patients.

Full description

With a prospective observational design, this study will examine whether there is a correlation between the total dose of cytostatics per measured fat-free mass (FFM) (mg cytostatic agent/kg FFM) and toxicity of cytostatics among cancer patients. The study will include patients with a primary diagnosis of any stage colorectal or pancreatic cancer.

The hypothesis is, that a higher total dose of cytostatics per FFM will correlate to more frequent and/or more severe toxicity than a lower total dose. In extension to this, we hypothesize that a loss of FFM during treatment, and thereby an increased total dose of cytostatics per FFM, will lead to more frequent and severe toxicity.

Recruitment and data collection will take place at the department of Clinical Oncology at Zealand University Hospital, Roskilde over about a five month period. Each patient will be included for two-four cycles of cytostatic treatment. FFM will be measured by bio impedance spectroscopy as close to the first day of each cycle of cytostatic treatment as possible. Information about toxicity will be obtained from patient records and through interviews with the patients. Interviews will be conducted at day 5 (4-6) of each cycle and at the end of each cycle. The interviews include questionnaires about specific toxicities, using National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and overall health and quality of life, and 24-hour recall of dietary intake and questions about physical activity level.

In short, relevant outcomes are change in FFM, hematology, grade 3/4 hematological toxicity as defined by NCI CTCAE, dose-limiting toxicity, hospitalization, patient-reported adverse events, overall health and quality of life, and nutritional intake.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Authorized individuals
• Understands, speaks and reads Danish
• Patients referred for or who receives cytostatic treatment, and have a primary diagnosis of colorectal- or pancreatic cancer (diagnoses classified by International Classification of Diseases-10 as C18-21 and C25)
• Have the possibility of contact by telephone

Exclusion criteria

• Pregnancy
• Breastfeeding
• Dementia
• Contraindications for BIS measuring (pacemaker)

Trial design

52 participants in 1 patient group

Patients with cancer receiving cytostatic treatment

Description:

Consecutive patients referred for cytostatic treatment or in treatment with cytostatic agents for colorectal or pancreatic cancer

Treatment:

Diagnostic Test: Bio Impedance Spectroscopy (BIS)