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:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT06019520
Eligibility Criteria:
Inclusion Criteria:
* Adult female outpatients with non-hematological malignancies (Breast, ovary and head and neck squamous cell carcinomas)
* Having Eastern Cooperative Oncology Group(ECOG) Performance Status ≤2 who had never received platinum based Chemotherapy in past and were now scheduled to receive high-dose cisplatin chemotherapy.
* Patients were required to have estimated glomerular filtration rate (GFR)(according to Cockcroft-Gault formula) ≥ 60 ml/min at start of chemotherapy regimen with normal Blood Counts, Liver, and kidney function tests
Exclusion Criteria:
* Patients who had poor performance status i.e., ECOG Performance Status 3 or 4
* Who declined to participate at any time during the course of the study
* Patients having hepatic failure (Liver Function tests \>3 times of upper limit normal)
* Patients who did not tolerate the use of NAC or were administered the drug \<70% of the time
* Patient who were receiving concurrent nephrotoxic drugs, or having history of Hypersensitivity to N-Acetyl cysteine.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06019520
Study Brief:
Protocol Section:
NCT06019520