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The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

RecruitingPhase 3Ages 18 Years - anyAllTanta University
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Children \< 18 years old. * Prior exposure to neurotoxic chemotherapy (Oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH) for at least 6 months prior the study treatment. * Evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes, brain tumor, brain trauma). * Patients with diabetes and other conditions that predispose to neuropathy as hypothyroidism, autoimmune diseases, hepatitis C. * History of known allergy to oxaliplatin or other platinum agents. * Patients with other inflammatory or stressful conditions. * Patients with glaucoma, cataract, other chronic eye disease, seizure, diabetes, heart diseases, low blood pressure, dizziness, vertigo, ménière's disease and CNS disorders. * Concomitant use of multivitamins (vitamins E, C, A), tricyclic antidepressants, other neuro-protective medications (gabapentin, lamotrigine, carbamazepine and phenytoin, etc…). * Patients on amifampridine, bupropion and donepezil. * Concurrent active cancer originating from a primary site other than colon or rectum. * Pregnant and breastfeeding women.
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What it tests

  • Placebo tablets
  • Ketotifen Oral Tablet
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Where

1 site
Oncology department Tanta university
Tanta, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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