Breast Cancer, Colorectal Cancer
Conditions
Keywords
Polymorphism, CES1, Capecitabine, Toxicity, Cancer
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.
Interventions
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.
Sponsors
Menoufia University
Ain Shams University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Contacts
Primary ContactRaghad Nassar, Teaching Assistant
Outcome results
None listed