Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity

April 26, 2026 updated by: Asmaa Bassem Mohammed, Minia University

Evaluation of Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity in Oncology Patients

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Minya Governorate
      • Minya, Minya Governorate, Egypt, 61111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Hydration
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.
Experimental: Alpha Lipoic Acid + Standard Hydration
  • 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)
The intervention under investigation is the administration of oral Alpha-Lipoic Acid (ALA) as an adjunct to standard cisplatin-based chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Quality of Life
Time Frame: Baseline; and end of study (Up to 6 weeks)
We will measure the patients' quality of life using the Arabic version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) questionnaire
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)

AKI is defined as o An increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 1.5 times baseline within 7 days; or

o A decrease in eGFR ≥ 25% from baseline; according to KDIGO acute kidney injury criteria.
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)
From cisplatin initiation through end of study (Up to 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Collaborators

Minia University Hospital

Investigators

  • Study Director: Ahmed Mostafa Abd-Elaziz, Department of Clinical Oncology, Faculty of Medicine, Minia University
  • Study Chair: Amal Kamal Hussein, Faculty of Pharmacy, Minia University
  • Study Director: Eman Mohamed Sadek, Faculty of Pharmacy, Minia University
  • Principal Investigator: Asmaa Basem Mohammed, Faculty of Pharmacy, Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 26, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPEC(260305)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the privacy of participants as the sample size is small and in one location

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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