The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

Launched by TANTA UNIVERSITY · Nov 16, 2022

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ClinConnect Summary

This clinical trial is investigating whether a medication called Ketotifen can help protect patients with stage III colorectal cancer from a side effect known as peripheral neuropathy, which can cause pain, tingling, and numbness in the hands and feet after receiving a chemotherapy drug called oxaliplatin. The study will involve 64 participants who will be randomly assigned to two groups: one group will receive the chemotherapy along with a placebo (a non-active tablet), while the other group will receive the chemotherapy along with Ketotifen. Throughout the study, researchers will monitor the participants for signs of neuropathy and collect blood samples to assess inflammation and other related factors.

To be eligible for this trial, participants must be adults aged 18 or older with a confirmed diagnosis of stage III colorectal cancer and scheduled to receive the modified FOLFOX-6 chemotherapy regimen. They should also have good blood and kidney function. However, individuals with certain conditions, previous nerve damage, or those taking specific medications may not qualify. Participants can expect to undergo assessments regularly to track their symptoms and overall health during the treatment. This study is important as it may provide insights into ways to reduce the painful side effects of chemotherapy, improving the quality of life for cancer patients.

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Eligibility criteria

• 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.