L-carnitine to protect kidneys from cisplatin damage

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.