Clinical Trials in Egypt / NCT07564479
Recruiting
Phase 2
Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity
NCT07564479 · tracked via the Priya Life Science Egypt tracker
Condition(s) studied
Cisplatin NephrotoxicityNephrotoxicity
Investigational drug(s) / intervention(s)
Alpha-Lipoic Acid (ALA): The intervention under investigation is the administration of oral Alpha-Lipoic Acid (ALA) as an adjunct to standard cisplatin-based chemotherapy.
Study summary
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes
Eligibility
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.
Primary outcome measure(s)
- Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group — Baseline, weekly up to 6 weeks
Measuring the change in Scr and CrCl in patients before and after they have a cumulative dose of 200mg/m2, depending on each patient's dosage regimen
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Minia University Hospital | Minya | Minya Governorate | Recruiting |
More Minia University trials in Egypt
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Colistin Nephrotoxicity and Role of Alpha Lipoic Acid
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07564479 on ClinicalTrials.gov ↗ ← All trials in Egypt