Trial reportJournal of gastrointestinal cancer2026
Ketotifen for Preventing Oxaliplatin-Induced Neuropathy in Stage III Colorectal Cancer: a Randomized Controlled Trial.
Trial report in Journal of gastrointestinal cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05624138 (The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
Who cites it
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeOxaliplatin-induced peripheral neuropathy (OIPN) is a frequent, dose-limiting toxicity in colorectal cancer and markedly impairs quality of life. This study aimed to evaluate the protective role of ketotifen in preventing OIPN, considering its mast-cell stabilizing, histamine H1 receptor-blocking, anti-inflammatory, and analgesic properties demonstrated in preclinical models. PATIENTS AND
methodsIn this randomized controlled trial, 64 patients with stage III colorectal cancer were assigned to two groups. The control group (n = 32) received the standard mFOLFOX-6 regimen for 12 cycles, whereas the ketotifen group (n = 32) received the same regimen plus ketotifen 2 mg orally once daily. Neuropathy prevention was assessed through serum biomarkers (neurotensin, superoxide dismutase, interleukin-6), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0), the 12-item neurotoxicity questionnaire (Ntx-12), and the Brief Pain Inventory-Short Form (BPI-SF).
resultsAfter 12 cycles, the ketotifen group showed a significant reduction in interleukin-6 and neurotensin levels (p < 0.0001), a lower incidence of grade 2-3 neuropathy (p = 0.001), reduced pain severity (p < 0.0001), and better Ntx-12 scores (p < 0.0001) compared with controls. Ketotifen was well tolerated and improved quality of sleep and appetite (p < 0.0001), addressing additional patient-reported challenges.
conclusionThis trial indicates that ketotifen may offer a promising approach for preventing OIPN. Larger placebo-controlled, double-blind, multicenter trials are needed to confirm these findings. CLINICALTRIAL: GOV IDENTIFIER: NCT05624138. TRIAL REGISTRATION DATE: 1-11-2022. CLINICAL TRIAL APPROVAL CODE: 36030/11/22.
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