Neuropathy;Peripheral Clinical Trial
Official title:
The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | November 2024 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with histologically confirmed diagnosis of Stage III colorectal cancer. - Patients who will be scheduled to receive modified FOLFOX-6. - Patients with no contraindication to chemotherapy. - Males and females aged = 18 years old. - Adequate baseline hematologic values (absolute neutrophilic count = 1.5 × 109/L, platelet count = 100 × 109/L and hemoglobin level = 10 g/dl). - Patients with adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance (ClCr) ? 45 mL/min). - Patients with adequate liver function (serum bilirubin < 1.5 mg/dl). - Patients with performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG) score. Exclusion Criteria: - Children < 18 years old. - Prior exposure to neurotoxic chemotherapy (Oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH) for at least 6 months prior the study treatment. - Evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes, brain tumor, brain trauma). - Patients with diabetes and other conditions that predispose to neuropathy as hypothyroidism, autoimmune diseases, hepatitis C. - History of known allergy to oxaliplatin or other platinum agents. - Patients with other inflammatory or stressful conditions. - Patients with glaucoma, cataract, other chronic eye disease, seizure, diabetes, heart diseases, low blood pressure, dizziness, vertigo, ménière's disease and CNS disorders. - Concomitant use of multivitamins (vitamins E, C, A), tricyclic antidepressants, other neuro-protective medications (gabapentin, lamotrigine, carbamazepine and phenytoin, etc…). - Patients on amifampridine, bupropion and donepezil. - Concurrent active cancer originating from a primary site other than colon or rectum. - Pregnant and breastfeeding women. |
Country | Name | City | State |
---|---|---|---|
Egypt | Oncology department Tanta university | Tanta | Other (Non U.s.) |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | variation in 12-item neurotoxicity questionnaire (Ntx-12) total score | the Ntx-12 questionnaire is comprised of 12 statements intended to measure the severity and impact of peripheral sensory neuropathy on patients' lives. Patients will be instructed to complete the Arabic version of the Ntx-12 and choose the number corresponding to how true each statement was for them using a likert-type scale, with 0 indicating not at all; 1, a little bit; 2, somewhat; 3, quite a bit; and 4, very much | 6 months (at baseline and after 2 oxaliplatin cycles( the cycle is every 15 days) | |
Primary | variation in pain rating scale score | 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. | 6 months (at baseline and after 2 oxaliplatin cycles( the cycle is every 15 days) | |
Primary | the percentage of patients with peripheral sensory neuropathy grade = 2 | Grading according to National Cancer Institute Common Terminology. there are 5 grades; Grade (1) is asymptomatic may be accompanied by loss of tendon reflex or paresthesia. Grade (2) is moderate symptoms which limit instrumental activities of daily life Grade (3) is severe symptoms which limit self-care activates of daily life. Grade (4) is life threatening consequences or urgent intervention indicated. Grade (5) is death.
Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) |
6 months | |
Secondary | changes in serum levels of the measured biological marker Serum IL-6 | as a marker of inflammation | 6 months (after 12 cycles and the cycle is every 15 days) | |
Secondary | changes in serum levels of the measured biological marker Serum SOD | as a biomarker of oxidative stress | 6 months(after 12 cycles and the cycle is every 15 days) | |
Secondary | changes in serum levels of the measured biological marker Serum neurotensin | biomarker for neuropathy | 6 months ( after 12 cycles and the cycle is every 15 days) |
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