|

Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

RECRUITINGPhase 2Sponsored by Ain Shams University
Actively Recruiting
PhasePhase 2
SponsorAin Shams University
Started2024-02-01
Est. completion2025-02-01
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Patients are eligible for inclusion if they meet the following criteria:

  * Cancer patients aged \>18 years receiving cisplatin-containing chemotherapy.
  * A cisplatin dose starting from 75 mg/m2.
  * Various cancer types.
  * Both males and females.
  * No history of organ transplantation or kidney dialysis.
  * Eastern cooperative oncology group performance (ECOG):0-2

Exclusion Criteria:

* Patients with peripheral neuropathy.
* Preexisting unilateral or bilateral moderate to severe sensorineural hearing loss
* Patients with speech discrimination affection or those who are unable to participate in audiologic evaluation
* Co-administration of ifosfamide with cisplatin, because of the known risk of nephrotoxicity.
* Pregnancy or lactation.
* Infection with the human immunodeficiency virus (HIV).
* Prior administration of cisplatin.
* Intraperitoneal chemotherapy.
* Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[ULN\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3 times the upper normal limit \[ULN\] or up to 5.0 upper normal limit \[ULN\] in the presence of hepatic metastases).
* Inadequate renal function (creatinine \> 1.25 times upper normal limit \[ULN\], creatinine clearance \< 50mL/min).
* Serious comorbid systemic disorder incompatible with the study (uncontrolled diabetes mellitus or hypertension, myocardial infarction within the last 6 months).
* Patients diagnosed with kidney cancer.
* Exposure to any nephrotoxic drugs or agents.

Conditions6

CancerCancer PatientsCisplatin Adverse ReactionCisplatin Induced Peripheral NeuropathyCisplatin NephrotoxicityCisplatin Ototoxicity

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.