Clinical trial · Interventional
Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity
Evaluation of Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity in Oncology Patients
NCT07564479CI-TRIAL-00110312recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cisplatin Nephrotoxicity | — | UNRESOLVED | — |
| Nephrotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha-Lipoic Acid (ALA) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard Hydration
- description
- o Standard preventive measures for cisplatin nephrotoxicity (e.g., pre and post hydration, antiemetics, magnesium and potassium supplementation as per unit protocol) will be applied.
- type
- EXPERIMENTAL
- label
- Alpha Lipoic Acid + Standard Hydration
- description
- * Patients will receive the same cisplatin based chemotherapy regimens and standard preventive measures as the control group. * In addition, they will receive oral alpha lipoic acid at a dose of \[e.g., 600 mg\] twice daily (ALA \[brand/formulation\], \[manufacturer, country\]) starting \[e.g., 2 days\] before the first cisplatin dose and continued throughout each chemotherapy cycle until 2 days after the last cisplatin administration in that cycle, for a total of 4 cycles
- interventionNames
- Drug: Alpha-Lipoic Acid (ALA)
Primary outcomes (1)
- measure
- Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDKim KH, Lee B, Kim YR, Kim MA, Ryu N, Jung DJ, Kim UK, Baek JI, Lee KY. Evaluating protective and therapeutic effects of alpha-lipoic acid on cisplatin-induced ototoxicity. Cell Death Dis. 2018 Aug 1;9(8):827. doi: 10.1038/s41419-018-0888-z. PMID 30068942
- BACKGROUNDFayez AM, Zakaria S, Moustafa D. Alpha lipoic acid exerts antioxidant effect via Nrf2/HO-1 pathway activation and suppresses hepatic stellate cells activation induced by methotrexate in rats. Biomed Pharmacother. 2018 Sep;105:428-433. doi: 10.1016/j.biopha.2018.05.145. Epub 2018 Jun 5. PMID 29879626
- BACKGROUNDDerosa G, D'Angelo A, Preti P, Maffioli P. Safety and Efficacy of Alpha Lipoic Acid During 4 Years of Observation: A Retrospective, Clinical Trial in Healthy Subjects in Primary Prevention. Drug Des Devel Ther. 2020 Dec 3;14:5367-5374. doi: 10.2147/DDDT.S280802. eCollection 2020. PMID 33299302
- BACKGROUNDRajeswaran A, Trojan A, Burnand B, Giannelli M. Efficacy and side effects of cisplatin- and carboplatin-based doublet chemotherapeutic regimens versus non-platinum-based doublet chemotherapeutic regimens as first line treatment of metastatic non-small cell lung carcinoma: a systematic review of randomized controlled trials. Lung Cancer. 2008 Jan;59(1):1-11. doi: 10.1016/j.lungcan.2007.07.012. Epub 2007 Aug 27. PMID 17720276