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

January 8, 2025 updated by: Raghad Essam Nassar, Ain Shams University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Drug: Capecitabine-based chemotherapy

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Raghad Nassar, Teaching Assistant
Phone Number: 002 01004446077
Email: raghad.essam22@pharma.asu.edu.eg

Study Locations

Egypt
- Menoufia
  - Shibīn Al Kawm, Menoufia, Egypt, 32511
    - Recruiting
    - Department of Clinical Oncology, Faculty of Medicine, Menoufia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Egyptian cancer patients presenting to the department of Clinical Oncology, Faculty of Medicine, Menoufia University.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of gastrointestinal toxicity Time Frame: 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.	Six months
Occurrence of hand-foot syndrome Time Frame: 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.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of hematological toxicity Time Frame: 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.	Six months
Occurrence of hepatic toxicity Time Frame: 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.	Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)