Actively Recruiting
Study on Genetic Differences Affecting Capecitabine Side Effects in Egyptian Patients With Colorectal and Breast Cancer Receiving Capecitabine-Based Chemotherapy
Led by Ain Shams University · Updated on 2025-01-09
80
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
A
Ain Shams University
Lead Sponsor
M
Menoufia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how a genetic variation in the CES1 gene (rs2244613) affects the side effects caused by capecitabine in Egyptian patients with breast or colorectal cancer. The study focuses on understanding why individuals respond differently to capecitabine-based chemotherapy and how this gene change may influence toxicity. It is an observational study involving patients already receiving this treatment as part of their regular care. Participants will be taking capecitabine orally at doses of 1,000-1,250 mg/m2 twice daily for the first 14 days of each 21-day treatment cycle. The study observes patients who are currently undergoing this chemotherapy regimen and does not involve altering their treatment. During the six months of observation, researchers will monitor for gastrointestinal toxicity and hand-foot syndrome, which are common side effects of capecitabine. Participants’ health status, including performance scores, will be assessed to understand the correlation between the genetic variation and treatment side effects. The study aims to gather data on how this genetic factor influences toxicity in real-world cancer treatment settings.
CONDITIONS
Official Title
Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with breast or colorectal cancer receiving capecitabine-based chemotherapy
- Age over 18 years
- ECOG performance status 0-2
You will not qualify if you...
- Patients treated with irinotecan
- Lack of physical integrity of the upper gastrointestinal tract
- Patients with malabsorption syndrome
- Patients unable to take oral medication
- Patients with poor performance status
- Patients with chronic diarrhea due to ulcerative colitis or Crohn's disease
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Trial Site Locations
Total: 1 location
1
Department of Clinical Oncology, Faculty of Medicine, Menoufia University
Shibīn al Kawm, Menoufia, Egypt, 32511
Actively Recruiting
Research Team
R
Raghad Nassar, Teaching Assistant
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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