Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID07108777

Clinical Study to Evaluate the Possible Protective Effect of L-Carnitine Against Cisplatin-Induced Nephrotoxicity

Led by Tanta University · Updated on 2025-08-12

46

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether L-carnitine can protect the kidneys from damage caused by cisplatin, a chemotherapy drug used to treat various solid tumors. Cisplatin is effective but can cause nephrotoxicity in 25-35% of patients due to its harmful effects on kidney tubules, oxidative stress, and inflammation. This study aims to understand if L-carnitine's antioxidant and anti-inflammatory properties can reduce this kidney damage in patients receiving cisplatin-based chemotherapy. Participants will be randomly assigned to one of two groups: one group will receive the standard cisplatin chemotherapy along with L-carnitine 350 mg taken orally three times daily, while the other group will receive the same chemotherapy with placebo tablets that look identical to the L-carnitine. This phase 2 trial uses a double-blind design, meaning neither participants nor researchers know which treatment each participant receives. During the study, participants' kidney function will be closely monitored by measuring changes in serum creatinine and creatinine clearance before chemotherapy cycles. Researchers will also evaluate safety and side effects. The study includes adults aged 18 to 75 years who are newly diagnosed with cancer and scheduled for at least three cycles of cisplatin chemotherapy. Participation will last through the chemotherapy treatment period, with ongoing assessments to track kidney health and treatment effects.

CONDITIONS

Brief Title

L-Carnitine Protective Effect in Nephrotoxicity

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients
  • Newly diagnosed with cancer and scheduled for cisplatin-based chemotherapy
  • Age between 18 and 75 years
  • No serious heart or lung conditions that could affect participation
  • Creatinine clearance above 50 mL/min/1.73 m²
  • Scheduled to receive at least 3 cycles of cisplatin chemotherapy
  • No previous kidney diseases including acute nephropathy or renal failure
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Cancer spread to the central nervous system
  • Psychiatric disorders
  • Previous treatment with platinum-based chemotherapy
  • Allergy to cisplatin, carboplatin, or other platinum drugs
  • Active infection or symptoms of sepsis
  • Recent acute kidney failure or kidney surgery within 3 months
  • Not fit for cisplatin due to kidney problems, hearing loss, or heart disease
  • Current use or history of nephrotoxic medications
  • Taking other antioxidant supplements such as Vitamins C or E

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of at least 3 chemotherapy cycles

Participants receive cisplatin-based chemotherapy along with either L-carnitine 350 mg or placebo three times daily by oral administration.

Visits aligned with chemotherapy cycles, typically 3 or more visits

Trial Site Locations

Total: 1 location

1

Menoufia Clinical Oncology Department, Menoufia University.

Shibīn al Kawm, Egypt

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Research Team

F

Fatma M Eweda, Master

F

Fatma M Eweda

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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