RecruitingPhase 3NCT05624138

The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer


Sponsor

Tanta University

Enrollment

64 participants

Start Date

Nov 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called ketotifen (an antihistamine/mast cell stabilizer) can protect patients from nerve damage caused by oxaliplatin chemotherapy. Nerve damage (peripheral neuropathy) — causing numbness and tingling in hands and feet — is a common and often treatment-limiting side effect of oxaliplatin, which is used to treat colorectal cancer. **You may be eligible if...** - You are 18 or older with stage III colorectal cancer confirmed by biopsy - You are scheduled to receive a standard chemotherapy regimen called FOLFOX-6 - Your blood counts, kidney function, and liver function are adequate - You have an ECOG performance score of 0–1 (fully active or restricted in strenuous activity only) **You may NOT be eligible if...** - You have had prior nerve-damaging chemotherapy (such as oxaliplatin, cisplatin, or taxanes) - You already have nerve damage from diabetes, tumors, or prior trauma - You have diabetes, hypothyroidism, autoimmune disease, or hepatitis C (conditions that also cause neuropathy) - You have glaucoma, heart disease, seizures, or severe eye conditions - You are taking vitamins E, C, or A, or certain neuropathy medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo tablets

12 cycles of modified FOLFOX-6 regimen (Oxaliplatin, Fluorouracil, calcium leucovorin) with 2 mg placebo tablets

DRUGKetotifen Oral Tablet

ketotifen is a potent anti histaminic drug that may prevent oxaliplatin induced peripheral neuropathy and mucositis and will be administered 2 mg daily along with the 12 cycles of modified Folfox-6 regimen


Locations(1)

Oncology department Tanta university

Tanta, Other, Egypt

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NCT05624138


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