L-Carnitine Protective Effect in Nephrotoxicity

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTanta University

About this trial

The goal of this clinical trial is to assess the possible reno-protective effect of L-carnitine against cisplatin-induced nephrotoxicity in patients receiving cisplatin-based chemotherapy. The main question it aims to answer is:

Does L-carnitine have the ability to protect the kidney against cisplatin-induced nephrotoxicity?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy or lactation.

Metastasis to the central nervous system.

Psychiatric disorders.

Prior treatment with platinum derivatives.

Trial design

Design model

Parallel

Treatments tested in this trial

  • L-Carnitine Tartrate

    Drug

    L-carnitine 350 mg three times daily by oral.

  • Placebo

    Drug

    placebo tablet three times daily by oral.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: L-carnitine groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

change in serum creatinine and creatinine clearance

serum creatinine average ranges are 0.7 to 1.2 (mg/dL) for males and 0.5 to 1.0 for females.

Time frame
Baseline (before chemotherapy cycles)

Secondary outcomes

Other outcomes

Sponsors and contacts

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