Evaluating Ketotifen's protective role against chemotherapy-induced nerve damage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of Ketotifen in preventing peripheral sensory neuropathy caused by oxaliplatin in patients with stage III colorectal cancer. It is a randomized, placebo-controlled study involving 64 participants who will receive either Ketotifen or a placebo alongside their chemotherapy regimen of modified FOLFOX-6. The study will monitor various biomarkers related to inflammation and oxidative stress, as well as evaluate the severity of neuropathy using standardized criteria. Participants will be recruited from the Oncology Department at Tanta University Hospital in Egypt.

Why it matters

Who can join: the full rules

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's running

• Oncology department Tanta university
  Tanta, Other, Egypt Recruiting

Study contacts

• Study coordinator: salma S wahby, Master
• Email: salmawahby135@outlook.com
• Phone: 00201111103067

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.