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ID07114627

Study on Capecitabine Effects and Hand-Foot Syndrome in Cancer Patients with Different CES1 Gene Types

Led by Erasmus Medical Center · Updated on 2025-08-11

66

Participants Needed

1

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating how the enzyme CES1 affects the way the drug capecitabine is processed in the body of cancer patients. Capecitabine is a common oral treatment for breast, colon, stomach, and other solid cancers. The study focuses on whether patients with a less effective CES1 enzyme have higher blood levels of the active drug molecule 5-FU and whether these patients experience more side effects like hand-foot syndrome, which causes redness and pain in the hands and feet. This research aims to better understand the causes of side effects related to capecitabine use. The study observes cancer patients treated with capecitabine combined with oxaliplatin CAPOX, sometimes alongside other anti-cancer drugs such as nivolumab, trastuzumab, or bevacizumab. Participants are grouped based on whether they carry a specific variant or the normal form of the CES1 gene. Extra blood samples will be collected to measure how capecitabine is metabolized in the body, focusing on the first 6 hours after taking the drug. Participants will be monitored for the amount of 5-FU in their blood and for side effects like hand-foot syndrome. Researchers will collect blood samples during treatment and assess patient health and side effects. The study involves adults who are starting standard treatment with capecitabine and oxaliplatin. The total participation time includes the initial treatment phase and follow-up assessments to understand the link between CES1 enzyme function and drug exposure.

CONDITIONS

Brief Title

Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients

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