The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
The aim of current study is to evaluate the possible protective role of Ketotifen against oxaliplatin-induced peripheral sensory neuropathy in patient with stage III colorectal cancer. This study will be a randomized placebo controlled parallel study.64 patients with colorectal cancer will be randomized to 2 groups: Group I (control group; n=32) which will receive 12 cycles of modified FOLFOX-6 regimen plus placebo tablets twice daily. Group II (ketotifen group; n=32) which will receive modified FOLFOX-6 regimen in addition to ketotifen 2 mg daily Blood sample collection and biochemical assessment: * Serum IL-6 as a marker of inflammation. * Serum superoxide dismutase (SOD) as a biomarker of oxidative stress. * Serum neurotensin as a biomarker for neuropathy. Assessment of oxaliplatin induced peripheral sensory neuropathy will be done through: * The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) for grading of neuropathy at baseline and by the end of every two oxaliplatin cycles. * The use of Neurotoxicity- 12 item questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group FACT/GOG-Ntx-12 at baseline and by the end of every two oxaliplatin cycles. * The assessment of the severity of neuropathic pain through brief pain inventory short form BPI-SF worst item. Severity of neuropathic pain will be assessed at baseline and by the end of every two oxaliplatin cycles.
• Patients with histologically confirmed diagnosis of Stage III colorectal cancer.
• Patients who will be scheduled to receive modified FOLFOX-6.
• Patients with no contraindication to chemotherapy.
• Males and females aged ≥ 18 years old.
• Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).
• Patients with adequate renal function (serum creatinine \< 1.5 mg/dl or creatinine clearance (ClCr) ˃ 45 mL/min).
• Patients with adequate liver function (serum bilirubin \< 1.5 mg/dl).
• Patients with performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG) score.