Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Capecitabine-based chemotherapy.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Occurrence of gastrointestinal toxicity [Time frame: Six months]
- Occurrence of hand-foot syndrome [Time frame: Six months]
Secondary outcome measures (2)
- Occurrence of hematological toxicity [Time frame: Six months]
- Occurrence of hepatic toxicity [Time frame: Six months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Department of Clinical Oncology, Faculty of Medicine, Menoufia University — Shibīn al Kawm
Identifiers
NCT: NCT06765252 · 4/2024ONCO16 · 281