Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients

Recruiting

• Conditions: Colorectal Cancer; Breast Cancer

• Registration Number: NCT06765252
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-11-12
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-04
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Occurrence of hematological toxicity	Six months	Occurrence and severity of capecitabine-induced hematological 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 hepatic toxicity	Six months	Occurrence and severity of capecitabine-induced hyperbilirubinemia 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 Locations

Locations (1)

Department of Clinical Oncology, Faculty of Medicine, Menoufia University; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt