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

Официальное название

N-Acetylcysteine Role on Urinary KIM-1 and Serum Creatinine Level in Cancer Patient With Cisplatin Based Chemotherapy

Обзор

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: 1. Does N-Acetylcysteine lower the level of KIM-1 (Kidney Injury Molecule) in patients urine indicating kidney function protection? 2. Does N-Acetylcysteine lower the level of creatinine in patients blood indicating kidney function protection? Participants will: 1. Had their blood and urine sample taken before taking the drugs (N-Acetylcysteine or placebo) 2. Underwent cisplatin based chemotherapy 3. Taken placebo or N-Acetylcysteine for seven days (1 day before chemotherapy, on the chemotherapy day, and 5 days after chemotherapy) 4. Had their blood and urine sample taken twice after taking the drugs (1 week and 3 weeks after chemotherapy) 5. Had their symptoms monitor during and after taking the drugs. Every possible side effect, hospitalization, or death will be recorded.

Вмешательства

• Препарат 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.
• Препарат Placebo
  Patient will get placebo

Первичные конечные точки

• Kidney injury molecule-1 [Срок оценки: 1 week and 3 weeks after intervention]
• Creatinine [Срок оценки: 1 week and 3 weeks after intervention]

Критерии участия

Критерии включения

• Patient with cancer/ malignancy proven by histopathological examination
• Patient with GFR ≥60 ml/mins/1,73 m²
• Patient with normal complete blood count and liver function test result
• Patient with good performance status (Karnofsky score ≥80)
• Patients with cisplatin based chemotherapy

Критерии исключения

• Patient that can not tolerate N-Acetylcysteine usage
• Patient with history of hypersensitivity to N-Acetylcysteine
• Patient that given other potentially nephrotoxic drug, such as furosemide, non-steroidal anti-infammatory drugs, aminoglycosides, amphotericin B, cephalosporine
• Patient that given other chemotherapy drug, such as permetrexed, ifosfamide, gemcitabin, bevacizumab, cetuxsimab
• Patient with history of malignant or uncontrolled hypertension
• patient with congestive heart failure, kidney structure abnormality, and acute infection
• Pregnant or lactating women
• Patient refusing to participate in the research

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07156786 · 25-02-0179

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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