The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy
Status:
Not yet recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
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.