Capecitabine-based chemotherapy: Participants receiving capecitabine in an oral dose of 1,000-1,250 mg/m2 twice daily for the first 14 days of each 21-day cycle.
Study summary
The goal of this observational study is to study the effect of a single nucleotide polymorphism in the CES1 gene (rs2244613) on capecitabine-induced toxicity in Egyptian cancer patients. This study will help in understanding the interindividual variability in the CES1 gene and the effect of a single nucleotide polymorphism in this gene (rs2244613) on capecitabine-induced toxicity in participants already taking capecitabine-based chemotherapy as part of their regular medical care.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with breast or colorectal cancer receiving capecitabine-based chemotherapy
* Age \> 18 years
* ECOG PS 0-2.
Exclusion Criteria:
* Patients treated with irinotecan
* Lack of physical integrity of the upper gastrointestinal tract
* Patients with malabsorption syndrome
* Patients having inability to take oral medication
* Patients with poor performance status
* Patients with chronic diarrhea as ulcerative colitis or Crohn's disease
Primary outcome measure(s)
Occurrence of gastrointestinal toxicity — Six months Occurrence and severity of capecitabine-induced gastrointestinal toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE V5.0) in relation to the variation in patients' genotype of rs2244613 in the CES1 gene.
Occurrence of hand-foot syndrome — Six months Occurrence and severity of capecitabine-induced Hand-foot syndrome will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE V5.0) in relation to the variation in patients' genotype of rs2244613 in the CES1 gene.
Trial sites (1)
Facility
City
Region
Status
Department of Clinical Oncology, Faculty of Medicine, Menoufia University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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