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

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

This study is testing if Ketotifen can help prevent nerve damage caused by chemotherapy in people with stage III colorectal cancer.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tanta University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tanta, Other)
• Trial ID: NCT05624138 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of stage III colorectal cancer who are scheduled to receive modified FOLFOX-6 chemotherapy.

Not a fit: Patients with pre-existing peripheral neuropathy or those who have previously received neurotoxic chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new preventive treatment option for patients undergoing chemotherapy, potentially reducing the incidence of debilitating nerve damage.

How similar studies have performed: While the protective role of Ketotifen in this specific context is novel, similar studies exploring neuroprotective agents in chemotherapy have shown varying degrees of success.

Eligibility criteria

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 this trial is running

Tanta, Other

• Oncology department Tanta university — Tanta, Other, Egypt (RECRUITING)

Study contacts

• Study coordinator: salma S wahby, Master

Conditions: Neuropathy, Peripheral