L-Carnitine Protective Effect in Nephrotoxicity

NCT07108777 | Recruiting Phase 2

• 1 other identifier: ONCO21
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Nephrotoxicity

Outcome Measures

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.

  Baseline (before chemotherapy cycles)

Study Arms (2)

L-carnitine group

ACTIVE COMPARATOR

This group will receive the standard chemotherapy protocol (cisplatin -based chemotherapy) plus L-carnitine 350 mg (L-carnitine®) three times daily by oral.

Drug: L-Carnitine Tartrate

Placebo group

PLACEBO COMPARATOR

This group will receive the standard chemotherapy protocol (cisplatin -based chemotherapy) plus placebo tablets with the same criteria of the intervention drug and the same dose.

Drug: Placebo

Interventions

L-Carnitine Tartrate DRUG

L-carnitine 350 mg three times daily by oral.

Also known as: L-Carnitine, Levocarnitine, carnitine

L-carnitine group

Placebo DRUG

placebo tablet three times daily by oral.

Also known as: Matching placebo, inactive control

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Menoufia Clinical Oncology Department, Menoufia University.

Shibīn al Kawm, Egypt

RECRUITING

MeSH Terms

Interventions

Carnitine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Fatma M Eweda, Master

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma M Eweda, Master

CONTACT

+201017045245; fatma.mamdouh7376@phrm.menofia.edu.eg

Fatma M Eweda

CONTACT

fatmamamdouh203@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)