Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity

NCT07564479 | Recruiting Phase 2

• 1 other identifier: MPEC(260305)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cisplatin Nephrotoxicity; Nephrotoxicity

Keywords

Cisplatin; Nephrotoxicity; ALA; Alpha-Lipoic Acid

Outcome Measures

Primary Outcomes (1)

• Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group

  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

  Baseline, weekly up to 6 weeks

Secondary Outcomes (3)

• Patients' Quality of Life

  Baseline; and end of study (Up to 6 weeks)

• Incidence of AKI ain patients receiving cisplatin

  From cisplatin initiation through end of study (Up to 6 weeks)

• Incidence of cisplatin dose reduction, delay, or discontinuation due to nephrotoxicity

  From cisplatin initiation through end of study (Up to 6 weeks)

Study Arms (2)

Standard Hydration

NO INTERVENTION

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.

Alpha Lipoic Acid + Standard Hydration

EXPERIMENTAL

* 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

Drug: Alpha-Lipoic Acid (ALA)

Interventions

Alpha-Lipoic Acid (ALA) DRUG

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

Alpha Lipoic Acid + Standard Hydration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead
• Minia University Hospital: collaborator

Study Sites (1)

Minia University Hospital

Minya, Minya Governorate, 61111, Egypt

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 2007 Aug 27.

  PMID: 17720276 BACKGROUND

MeSH Terms

Interventions

Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Ahmed Mostafa Abd-Elaziz

  Department of Clinical Oncology, Faculty of Medicine, Minia University

  STUDY DIRECTOR

• Amal Kamal Hussein

  Faculty of Pharmacy, Minia University

  STUDY CHAIR

• Eman Mohamed Sadek

  Faculty of Pharmacy, Minia University

  STUDY DIRECTOR

• Asmaa Basem Mohammed

  Faculty of Pharmacy, Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa Mohammed

CONTACT

00201090824147; asmaa.bashandy@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching and Research Assistant

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 4, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)