Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06765252

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Colorectal Cancer Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Oncology, Faculty of Medicine, Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine-based chemotherapy

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Raghad Nassar, Teaching Assistant

CONTACT

[email protected]

01004446077 ext. 002

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Menoufia University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.