Clinical trial · Interventional
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
NCT06297369CI-TRIAL-00074811unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients | — | UNRESOLVED | — |
| Cisplatin Adverse Reaction | — | UNRESOLVED | — |
| Cisplatin Induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Cisplatin Nephrotoxicity | — | UNRESOLVED | — |
| Cisplatin Ototoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N acetyl cysteine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control group
- description
- a. Group 1 (Control group, N = 30 patients) which will include patients who will receive cisplatin chemotherapy starting from 75mg/m2 for 4 cycles (21-28 days and or fractionated)
- type
- ACTIVE_COMPARATOR
- label
- treatment group
- description
- b. Group 2 (N = 30 patients) will receive N-acetylcysteine 600 mg twice daily (Acetylcystein ® 600 mg effervescent instant granules sachets, Sedico, Egypt) with cisplatin chemotherapy for 4 cycles (21-28 days and or fractionated)
- interventionNames
- Drug: N acetyl cysteine
Primary outcomes (1)
- measure
- The occurrence of cisplatin-induced ototoxicity in the form of hearing loss.
- timeFrame
- 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.