NCT04528745

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Pancreas Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bio Impedance Spectroscopy (BIS)	Determination of fat free mass by BIS

Timeline

• Start date: 2020-05-04
• Primary completion: 2020-10-09
• Completion: 2020-11-30
• First posted: 2020-08-27
• Last updated: 2021-09-29

Locations

1 site across 1 country: Denmark