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Cisplatin is one of the first-line drugs used against many malignancies, such as lung cancer, head and neck cancer, esophageal cancer, gastric cancer, colorectal cancer, urothelial cancer, bladder cancer and testicular cancer. The usage of Cisplatin is limited by its severe nephrotoxicity, which particularly affects the proximal tubule epithelial cells (PTEC).Several studies suggest role of NAC in ameliorating Cisplatin induced nephrotoxicity, although definitive data is lacking. N-Acetylcysteine (NAC) is a thiol-containing antioxidant, which not only acts as a precursor of glutathione but also as a direct antioxidant .There are multiple postulated mechanisms for NAC's nephroprotection. NAC is a low-cost, easily available drug with a very good safety profile and therefore can be added as a support medication during treatment with cisplatin. The investigators plan to administer 1200 mg oral NAC 12 hours before chemotherapy and then daily at night for the subsequent 6 days, with an objective to ascertain its nephroprotective role in population receiving Cisplatin/-based chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin group | Active Comparator | This group of Patients will receive Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol |
|
| N-acetylcysteine group | Experimental | Patients in the NAC arm to be given N-acetylcysteine 1200 mg/day starting 12 hrs before till 6 days after Cisplatin-based chemotherapy administration. Hydration according to standard hydration protocol will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetylcysteine | Drug | Patients in the NAC arm will receive1200 mg of NAC (water-soluble granule Preparation) administered orally once daily at night for 7 consecutive days (1 days before chemotherapy, on the day of chemotherapy, and 5 days after chemotherapy) in each cycle of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine of participant | Blood samples collected and measured in laboratory with the unit mg/dL | 18 weeks |
| Creatinine clearance of participant | It will be calculated using Cockroft-Gault formula , unit ml/min | 18 weeks |
| Estimation of Acute kidney injury to participant | Acute kidney injury will be assessed by RIFLE criteria that will be calculated for patients | 18 weeks |
| Blood urea nitrogen of participant | Blood samples collected and measured in laboratory with the unit mg/dl | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The study includes adult female outpatients with non-hematological malignancies
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Oncology department, Fauji Foundation Hospital | Rawalpindi | Punjab Province | 46000 | Pakistan |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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It will be a two-arm study with 35 patients in each arm. After taking informed consent, a total of 70 patients will be enrolled. The patients will be enrolled by convenience nonprobability sampling technique. Then they will be randomized to the N-Acetylcysteine plus chemotherapy and chemotherapy-alone arms.
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|
| Chemotherapy | Drug | Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol. |
|
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |