drugset / Trial / NCT07476443

Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity

NCT07476443

Phase 2/3 Not yet recruiting 75 enrolled Ain Shams University
RandomizedParallel-groupOpen-labelPrevention

Summary

Cisplatin is a widely used chemotherapy drug for many solid tumors (e.g., lung, bladder, ovarian, head and neck cancers). Despite its efficacy, its clinical use is limited by severe side effects, mainly nephrotoxicity, which occurs in \~30% of patients after treatment. Once inside cells, cisplatin undergoes activation, leading to DNA and mitochondrial damage, oxidative stress, inflammation, apoptosis, and eventual acute kidney injury (AKI) or chronic kidney disease (CKD). Vitamin C (ascorbic acid) is a water-soluble antioxidant with broad protective roles, including free radical scavenging, DNA and protein protection, and glutathione restoration. Coenzyme Q10 (CoQ10) is a lipid-soluble antioxidant involved in mitochondrial energy production and regeneration of other antioxidants (vitamins C \& E). Both antioxidants are generally safe at studied doses, with only mild gastrointestinal side effects reported. Therefore, evaluating their role in preventing cisplatin-induced nephrotoxicity in cancer patients is clinically valuable. Aim of the study : This study aims to evaluate the protective effects of (Vitamin C and Coenzyme q10) against cisplatin-induced nephrotoxicity in chemotherapy-naïve cancer patients.

Timeline

Start
2026-04-20
Primary completion
2027-05-20
Completion
2027-08-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Coenzyme Q10 Other / unclassified 30 mg Oral
Comparator Vitamin C Other / unclassified 500 mg Oral

Indications