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Purpose <p>Oxaliplatin-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.</p> Patients and Methods <p>In this randomized controlled trial, 64 patients with stage III colorectal cancer were assigned to two groups. The control group (<i>n</i> = 32) received the standard mFOLFOX-6 regimen for 12 cycles, whereas the ketotifen group (<i>n</i> = 32) received the same regimen plus ketotifen 2&#xa0;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).</p> Results <p>After 12 cycles, the ketotifen group showed a significant reduction in interleukin-6 and neurotensin levels (<i>p</i> &lt; 0.0001), a lower incidence of grade 2–3 neuropathy (<i>p</i> = 0.001), reduced pain severity (<i>p</i> &lt; 0.0001), and better Ntx-12 scores (<i>p</i> &lt; 0.0001) compared with controls. Ketotifen was well tolerated and improved quality of sleep and appetite (<i>p</i> &lt; 0.0001), addressing additional patient-reported challenges.</p> Conclusion <p>This 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.</p> ClinicalTrial.gov Identifier <p>NCT05624138.</p> Trial registration date <p>1-11-2022.</p> Clinical trial approval code <p>36030/11/22.</p>

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Ketotifen for Preventing Oxaliplatin-Induced Neuropathy in Stage III Colorectal Cancer: a Randomized Controlled Trial

  • 期刊论文

  • 发表日期：

    2026年5月7日

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  • Salma S. Wahby,
  • Tarek M. Mostafa,
  • Mohamed A. Alm El-Din,
  • Eman I. Elberri

摘要

Purpose

Oxaliplatin-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 Methods

In 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).

Results

After 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.

Conclusion

This 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.