Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer
Launched by AIN SHAMS UNIVERSITY · Apr 27, 2015
Trial Information
Current as of October 30, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is an observational study in Cairo, Egypt, looking at whether certain genetic changes in the ABCG2 gene are connected to nerve problems caused by the chemotherapy drug oxaliplatin in people with gastrointestinal tract cancers. Researchers will take a blood sample to test for two ABCG2 gene changes and will compare these findings with how severe nerve side effects are, using a standard toxicity scale, after about six cycles of oxaliplatin-containing treatment over roughly six months. This study does not test a new drug and is not designed to change your treatment plan; it aims to learn why some patients develop nerve problems more than others.
Who may be eligible and what to expect: Adults aged 18 to 80 with gastrointestinal tract cancer who are receiving oxaliplatin-containing chemotherapy and have measurable disease may be eligible. Exclusions include pregnancy, a history of allergic reactions to similar drugs, any uncontrolled illness, or existing nerve problems that could affect nerve function. If you participate, you’ll have a blood draw for genetic testing and will have nerve side effect assessments at each chemotherapy cycle. The study is being conducted at Ain Shams University hospitals in Cairo, with about 80 participants planned. Results are not available yet.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Gastrointestinal Tract Cancer patients treated with Oxaliplatin-containing chemotherapy
- • Measurable disease
- • Age of 18 years to 80 years
- Exclusion Criteria:
- • Pregnant women
- • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oxaliplatin.
- • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- • Neurologic disease or patients with disease impairing the neurologic function affecting
About Ain Shams University
Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, Abbasia, Egypt
Patients applied
Trial Officials
Inas M Moukhtar Ahmed, B.pharma
Principal Investigator
Faculty of Pharmacy, Ain Shams Universty
Lamia M El Wakeel, Assoc. Prof
Study Director
Clinical Pharmacy, Ain Shams University
Abdel Hady A Abdel Wahab, Professor
Study Chair
Biochemistry & Molecular biology,Cairo University
Amr S Saad, Assoc. Prof
Study Chair
Clinical Oncology, Ain Shams University
Raafat R Abdel-Malek, Assoc. Prof
Study Chair
clinical oncology, cairo university
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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