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

NCT06765252 | Recruiting

• 2 other identifiers: 4/2024ONCO16281
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Breast Cancer

Keywords

Polymorphism; CES1; Capecitabine; Toxicity; Cancer

Outcome Measures

Primary Outcomes (2)

• Occurrence of gastrointestinal toxicity

  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

  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 Outcomes (2)

• Occurrence of hematological toxicity

  Six months

• Occurrence of hepatic toxicity

  Six months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with breast or colorectal cancer receiving capecitabine-based chemotherapy
• Age \> 18 years
• ECOG PS 0-2.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead
• Menoufia University: collaborator

Study Sites (1)

Department of Clinical Oncology, Faculty of Medicine, Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Raghad Nassar, Teaching Assistant

CONTACT

01004446077; raghad.essam22@pharma.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant, Clinical Pharmacy Department, Faculty of Pharmacy, Menoufia University

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: January 9, 2025
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

EG (1)