NCT07564479 Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity
| NCT ID | NCT07564479 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Minia University |
| Condition | Cisplatin Nephrotoxicity |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-10 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-03-10 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes
Eligibility 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.
Contact & Investigator
Ahmed Mostafa Abd-Elaziz
STUDY DIRECTOR
Department of Clinical Oncology, Faculty of Medicine, Minia University
Frequently Asked Questions
Who can join the NCT07564479 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cisplatin Nephrotoxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07564479 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07564479 currently recruiting?
Yes, NCT07564479 is actively recruiting participants. Contact the research team at asmaa.bashandy@mu.edu.eg for enrollment information.
Where is the NCT07564479 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07564479 clinical trial?
NCT07564479 is sponsored by Minia University. The principal investigator is Ahmed Mostafa Abd-Elaziz at Department of Clinical Oncology, Faculty of Medicine, Minia University. The trial plans to enroll 50 participants.