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NCT Number: NCT07564479

Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity

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

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Key information

Conditions

Cisplatin Nephrotoxicity Nephrotoxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa Mohammed

CONTACT

[email protected]

00201090824147

Sponsors and collaborators

Lead sponsor

Minia University

Other

Collaborators

  • Minia University Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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