RecruitingPhase 2NCT07564479

Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity

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

Sponsor

Minia University

Enrollment

50 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

Nephrotoxicity Cisplatin Nephrotoxicity

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria4

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.

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Interventions

DRUGAlpha-Lipoic Acid (ALA)

The intervention under investigation is the administration of oral Alpha-Lipoic Acid (ALA) as an adjunct to standard cisplatin-based chemotherapy.

Locations(1)

Minia University Hospital

Minya, Minya Governorate, Egypt

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NCT07564479

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