Alpha-lipoic acid to help protect kidneys during cisplatin chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, randomized, open-label, parallel-group trial will assign adults with solid tumors who are starting cisplatin (≥60 mg/m2) to receive oral alpha-lipoic acid or standard care in a 1:1 ratio. Participants will be followed across chemotherapy cycles with regular monitoring of serum creatinine and eGFR to detect changes in renal function. The proof-of-concept design compares the incidence and degree of cisplatin-induced nephrotoxicity between the ALA and control groups. The trial is conducted at a single center (Minia University Hospital) and both patients and clinicians will know treatment assignments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Minia University Hospital
  Minya, Minya Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Asmaa Basem Mohammed — Faculty of Pharmacy, Minia University
• Study coordinator: Asmaa Mohammed
• Email: asmaa.bashandy@mu.edu.eg
• Phone: 00201090824147

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.