Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity

Evaluation of Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity in Oncology Patients

To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes

This proof-of-concept study will be a randomized, controlled, open label clinical trial with parallel group assignment, designed to evaluate the nephroprotective effect of alpha lipoic acid (ALA) in patients receiving cisplatin based chemotherapy.

• Allocation: Randomized (1:1).
• Interventional model: Parallel assignment.
• Masking: None (open label).

Inclusion Criteria:

• Age ≥ 18 years. Histologically confirmed solid malignancy. Planned treatment with cisplatin starting from a dose of 60 mg/m2 per cycle (21-28 days each or fractionated).

Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Baseline serum creatinine within normal range or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2.

Ability to provide informed consent.

Exclusion Criteria:

• Pre existing renal impairment (eGFR < 60〖" mL/min/1.73 m" 〗^2or serum creatinine > 1.5 × upper limit of normal).

Concomitant use of known nephrotoxic drugs that cannot be stopped (e.g., aminoglycosides, amphotericin B, high dose NSAIDs).

Uncontrolled hypertension, decompensated heart failure, or severe hepatic impairment.

Known allergy or intolerance to ALA. Pregnancy or lactation. Participation in another interventional clinical trial.