L-carnitine to protect kidneys from cisplatin damage
Clinical Study to Evaluate the Possible Protective Effect of L-Carnitine Against Cisplatin-Induced Nephrotoxicity
This trial will test if L-carnitine can help protect the kidneys of adults receiving cisplatin-based chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shibīn al Kawm) |
| Trial ID | NCT07108777 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives adult patients L-carnitine tartrate or a placebo alongside planned cisplatin-based chemotherapy and tracks kidney function over at least three cycles. Participants must have adequate baseline renal function and no prior platinum therapy. The rationale is that L-carnitine's antioxidant and anti-inflammatory effects reduced cisplatin kidney injury in animal models. Kidney function and signs of nephrotoxicity will be monitored to compare outcomes between the L-carnitine and placebo groups.
Who should consider this trial
Good fit: Adults aged 18–75 with newly diagnosed cancer who are scheduled to receive at least three cycles of cisplatin-based chemotherapy and who have creatinine clearance above 50 mL/min/1.73 m² and no prior renal disease or prior platinum therapy.
Not a fit: Patients with existing renal disease, prior treatment with platinum drugs, inability to receive cisplatin, pregnancy/lactation, or active severe infection are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, L-carnitine could reduce cisplatin-related kidney damage and help patients complete planned chemotherapy with fewer interruptions or dose reductions.
How similar studies have performed: Animal studies have shown that L-carnitine can ameliorate cisplatin-induced renal damage, but clinical evidence in humans remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients. * Newly diagnosed patients with cancer and with an indication for cisplatin - based chemotherapy. * Age between 18 and 75 years. * No serious cardiopulmonary comorbidity which could impair involvement in the study. * Creatinine clearance value above 50 mL/min/1.73 m². * Patients who will scheduled to receive at least 3 cycles of cisplatin. * Patients with no previous renal diseases (including acute nephropathy, acute and chronic renal failure). Exclusion Criteria: * Pregnancy or lactation. * Metastasis to the central nervous system. * Psychiatric disorders. * Prior treatment with platinum derivatives. * Hypersensitivity to cisplatin, carboplatin or other platinum derivatives. * Patients with active infection or any symptoms of sepsis. * Acute renal failure or renal surgery within the last 3 months. * Patients unfit for cisplatin (patients with impaired renal function, sensorineural hearing loss and cardiomyopathy). * Patients with known history or current treatment with nephrotoxic agents. * Taking other antioxidant supplements such as Vitamins C and E.
Where this trial is running
Shibīn al Kawm
- Menoufia Clinical Oncology Department, Menoufia University. — Shibīn al Kawm, Egypt (Recruiting)
Study contacts
- Principal investigator: Fatma M Eweda, Master — Tanta University
- Study coordinator: Fatma M Eweda, Master
- Email: fatma.mamdouh7376@phrm.menofia.edu.eg
- Phone: +201017045245
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.