Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06297369
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06297369
Study Brief:
Protocol Section:
NCT06297369