The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy
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ABSTRACT: 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.
DISEASE(S): Peripheral Nervous System Diseases,Neuropathy;peripheral
PROVIDER: 488 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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