The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy
Recruiting · NCT05624138 · Interventional (participants receive a specific treatment) · Lead sponsor: Tanta University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Oncology department Tanta university - Tanta, Other, Egypt