T-1210

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.

In order to validate the accuracy and reliability of the histamine skin prick model for histaminergic itch and vasodilation, the dermal blood flow response induced by a histamine skin prick will be evaluated after the administration of certain antipruritics. Besides, the influence of these antipruritics on the dermal blood flow response induced by the topical application of cinnamaldehyde and capsaicin will be evaluated. Changes in dermal blood flow will be measured with laser speckle contrast imaging.