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Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity

RECRUITINGPhase 2Sponsored by Minia University
Actively Recruiting
PhasePhase 2
SponsorMinia University
Started2026-03-10
Est. completion2027-03
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

CancerCisplatin NephrotoxicityNephrotoxicity

Interventions1

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