Ketotifen for Preventing Oxaliplatin-Induced Neuropathy in Stage III Colorectal Cancer: a Randomized Controlled Trial.
Salma S Wahby, Tarek M Mostafa, Mohamed A Alm El-Din...
https://pubmed.ncbi.nlm.nih.gov/42096115Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05624138
The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
Led by Tanta University · Updated on 2025-05-11
64
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the potential protective effect of ketotifen against peripheral sensory neuropathy caused by oxaliplatin in patients with stage III colorectal cancer. This randomized, placebo-controlled trial involves 64 patients who will receive chemotherapy with either ketotifen or placebo alongside their treatment. The study aims to monitor neuropathy symptoms and related biological markers to assess ketotifen's role in reducing nerve damage during chemotherapy. Participants will be randomly assigned to one of two groups. The first group receives 12 cycles of modified FOLFOX-6 chemotherapy plus placebo tablets twice daily. The second group receives the same chemotherapy regimen along with 2 mg of oral ketotifen daily throughout the 12 chemotherapy cycles. Chemotherapy cycles occur every two weeks and include intravenous oxaliplatin, leucovorin, and fluorouracil infusions. All participants also receive medications to prevent nausea and mucositis before each cycle. Throughout the study, researchers will collect blood samples to measure inflammation, oxidative stress, and neuropathy biomarkers. Peripheral sensory neuropathy will be assessed using the National Cancer Institute grading criteria, the Neurotoxicity-12 questionnaire, and a neuropathic pain inventory at baseline and after every two chemotherapy cycles. The study monitors changes over six months, with the primary outcomes focused on neuropathy symptoms and pain scores. Safety and treatment effects will be carefully observed during this period.
CONDITIONS
Brief Title
The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed diagnosis of Stage III colorectal cancer.
- Patients scheduled to receive modified FOLFOX-6 chemotherapy.
- Patients with no contraindication to chemotherapy.
- Male and female patients aged 18 years or older.
- Adequate baseline blood counts (neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 10 g/dl).
- Adequate kidney function (serum creatinine < 1.5 mg/dl or creatinine clearance ≥ 45 mL/min).
- Adequate liver function (serum bilirubin < 1.5 mg/dl).
- Performance status 0-1 according to Eastern Cooperative Oncology Group score.
You will not qualify if you...
- Children under 18 years old.
- Prior neurotoxic chemotherapy (including oxaliplatin, cisplatin, vincristine, paclitaxel, docetaxel, INH) within 6 months before study treatment.
- Existing peripheral neuropathy from other causes such as diabetes, brain tumor, or brain trauma.
- Patients with diabetes or conditions predisposing to neuropathy like hypothyroidism, autoimmune diseases, or hepatitis C.
- History of allergy to oxaliplatin or other platinum-based drugs.
- Presence of other inflammatory or stressful conditions.
- Patients with glaucoma, cataract, chronic eye diseases, seizure disorders, heart diseases, low blood pressure, dizziness, vertigo, Ménière's disease, or central nervous system disorders.
- Use of multivitamins (E, C, A), tricyclic antidepressants, or other neuro-protective medications (gabapentin, lamotrigine, carbamazepine, phenytoin).
- Use of amifampridine, bupropion, or donepezil.
- Active cancer originating from sites other than colon or rectum.
- Pregnant or breastfeeding women.
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 6 months
Participants receive 12 cycles of modified FOLFOX-6 chemotherapy every 2 weeks, combined with either ketotifen 2 mg daily or placebo tablets daily throughout the chemotherapy cycles. Neuropathy and pain assessments are done at baseline and after every two chemotherapy cycles.
Visits every 2 weeks for 12 cycles; neuropathy and pain assessments at baseline and every 2 cycles
Trial Site Locations
Total: 1 location
1
Oncology department Tanta university
Tanta, Other, Egypt, 31511
Actively Recruiting
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Research Team
S
salma S wahby, Master
T
Tarek M mostafa, Professor of clinical pharmacy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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