Alpha-lipoic acid to help protect kidneys during cisplatin chemotherapy
Evaluation of Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity in Oncology Patients
This trial will see if taking alpha-lipoic acid can prevent kidney damage in adults receiving cisplatin chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07564479 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with a confirmed solid malignancy, ECOG performance status 0–2, normal baseline renal function (eGFR ≥60 mL/min/1.73 m2), and planned cisplatin at or above 60 mg/m2 per cycle are ideal candidates.
Not a fit: Patients with pre-existing renal impairment (eGFR <60 mL/min/1.73 m2), those on unavoidable nephrotoxic drugs, pregnant or breastfeeding people, or anyone with known allergy to ALA are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, alpha-lipoic acid could lower the risk of cisplatin-related kidney damage and help patients tolerate chemotherapy more safely.
How similar studies have performed: Preclinical data and small clinical reports suggest antioxidants like ALA may protect against cisplatin nephrotoxicity, but robust randomized clinical evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minya, Minya Governorate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.