Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alpha-Lipoic Acid (ALA).
- Who it may be relevant to
- Registry conditions: Cisplatin Nephrotoxicity, Nephrotoxicity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity in Oncology Patients
Overview
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes
Detailed description
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).
Interventions
- Drug 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.
Primary outcome measures
- Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group [Time frame: Baseline, weekly up to 6 weeks]
Secondary outcome measures (3)
- Patients' Quality of Life [Time frame: Baseline; and end of study (Up to 6 weeks)]
- Incidence of AKI ain patients receiving cisplatin [Time frame: From cisplatin initiation through end of study (Up to 6 weeks)]
- Incidence of cisplatin dose reduction, delay, or discontinuation due to nephrotoxicity [Time frame: From cisplatin initiation through end of study (Up to 6 weeks)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Minia University Hospital — Minya
Publications
- Kim 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
- Fayez 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
- Derosa 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
- Rajeswaran 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 PMID 17720276
Identifiers
NCT: NCT07564479 · MPEC(260305)