[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604997":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":40,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":26,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":26,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":60,"conditions":61,"keywords":67,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Fakultas Kedokteran Universitas Indonesia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Patient receiving placebo and cisplatin chemotherapy",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"N-Acetylcysteine","EXPERIMENTAL","Patient receiving NAC + cisplatin based chemotherapy",[19],"Drug: N-acetylcysteine (NAC)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","N-acetylcysteine (NAC)","N-Acetylcysteine effercescent 1200 mg orally twice a day for 7 days. One day before cisplatin based chemotherapy, on the chemotherapy day, and five days after.",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"Patient will get placebo",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Oryza G Prabu, MD, Specialist","CONTACT","+62 821 1113 3822","oryza.gyragus@gmail.com",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"Pringgodigdo Nugroho, MD, Doctor","+62 817 9822 504","pringgo@gmail.com",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Oryza Gryagus Prabu, MD","Medical Staff, Internist","100604997","phase-2-n-acetylcysteine-roles-in-preserving-renal-function-measured-by-urinary-kim-1-kidney-injury-molecule-1-and-serum-creatinine-on-cancer-patients-with-cisplatin-based-chemotherapy-a-randomized-placebo-controlled-trial-100604997",false,"NCT07156786","N-Acetylcysteine Roles in Preserving Renal Function Measured by Urinary KIM-1 (Kidney Injury Molecule-1) and Serum Creatinine on Cancer Patients With Cisplatin Based Chemotherapy: A Randomized Placebo-Controlled Trial","N-Acetylcysteine Role on Urinary KIM-1 and Serum Creatinine Level in Cancer Patient With Cisplatin Based Chemotherapy","Inclusion Criteria:\n\n* Patient with cancer\u002F malignancy proven by histopathological examination\n* Patient with GFR ≥60 ml\u002Fmins\u002F1,73 m²\n* Patient with normal complete blood count and liver function test result\n* Patient with good performance status (Karnofsky score ≥80)\n* Patients with cisplatin based chemotherapy\n\nExclusion Criteria:\n\n* Patient that can not tolerate N-Acetylcysteine usage\n* Patient with history of hypersensitivity to N-Acetylcysteine\n* Patient that given other potentially nephrotoxic drug, such as furosemide, non-steroidal anti-infammatory drugs, aminoglycosides, amphotericin B, cephalosporine\n* Patient that given other chemotherapy drug, such as permetrexed, ifosfamide, gemcitabin, bevacizumab, cetuxsimab\n* Patient with history of malignant or uncontrolled hypertension\n* patient with congestive heart failure, kidney structure abnormality, and acute infection\n* Pregnant or lactating women\n* Patient refusing to participate in the research","ALL","18 Years",{"count":54,"type":55},72,"ESTIMATED","INTERVENTIONAL",[58,59],"PHASE2","PHASE3","The goal of this clinical trial is to learn if N-Acetylcysteine drug works to protect kidney function in adults patient with cancer. Kidney function will be measured by laboratory parameter using urine sample (KIM-1 urine) and blood sample (serum creatinine). The main questions it aims to answer are:\n\n1. Does N-Acetylcysteine lower the level of KIM-1 (Kidney Injury Molecule) in patients urine indicating kidney function protection?\n2. Does N-Acetylcysteine lower the level of creatinine in patients blood indicating kidney function protection?\n\nParticipants will:\n\n1. Had their blood and urine sample taken before taking the drugs (N-Acetylcysteine or placebo)\n2. Underwent cisplatin based chemotherapy\n3. Taken placebo or N-Acetylcysteine for seven days (1 day before chemotherapy, on the chemotherapy day, and 5 days after chemotherapy)\n4. Had their blood and urine sample taken twice after taking the drugs (1 week and 3 weeks after chemotherapy)\n5. Had their symptoms monitor during and after taking the drugs. Every possible side effect, hospitalization, or death will be recorded.",[62,63,64,65,66],"Kidney Function Issue","Acute Kidney Injury","Cancer (Solid Tumors)","Kidney Function Tests","Acetylcysteine Adverse Reaction",[68,69,70,15],"kidney injury molecule 1","KIM-1","Creatinine","NOT_YET_RECRUITING","2025-09-13",{"date":74,"type":75},"2025-09-19","ACTUAL",{"date":77,"type":55},"2025-09-15",{"date":79,"type":55},"2027-08-31",{"name":5,"class":6}]