The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Oncology department Tanta university
RECRUITING
Tanta
Contact Information
Primary
salma S wahby, Master
salmawahby135@outlook.com
00201111103067
Backup
Tarek M mostafa, Professor of clinical pharmacy
tarek.mostafa@pharm.tanta.edu.eg
01154594035
Time Frame
Start Date: 2022-11-09
Estimated Completion Date: 2025-06
Participants
Target number of participants: 64
Treatments
Placebo_comparator: placebo
Group I Placebo group n=32 Patients will receive 12 cycles of modified FOLFOX-6 regiment plus placebo tablets 2mg daily throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every 2 weeks and will be as follows:~Day 1 and Day 15: Oxaliplatin 85 mg/m2 intravenous infusion in 250-500 mL 5% dextrose solution and leucovorin 400 mg/m2 intravenous infusion in 5% dextrose solution both were given over 120 minutes at the same time in separate bags using a Y-line access, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2-4 minutes, followed by 5-fluorouracil 2400 mg/m2 intravenous infusion in 500 mL 5% dextrose solution as a 46-hour infusion.
Active_comparator: ketotifen oral tablets
Group II ketotifen group n=32 Patients will receive 12 cycles of modified FOLFOX-6 regiment plus ketotifen tablets 2mg daily throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every 2 weeks and will be as follows:~Day 1 and Day 15 : Oxaliplatin 85 mg/m2 intravenous infusion in 250-500 mL 5% dextrose solution and leucovorin 400 mg/m2 intravenous infusion in 5% dextrose solution both were given over 120 minutes at the same time in separate bags using a Y-line access, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2-4 minutes, followed by 5-fluorouracil 2400 mg/m2 intravenous infusion in 500 mL 5% dextrose solution as a 46-hour infusion
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov