Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT06297369
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081015', 'term': 'Ototoxicity'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': 'hearing loss will be assessed using audiometry'}], 'secondaryOutcomes': [{'measure': 'The occurrence of cisplatin-induced nephrotoxicity.', 'timeFrame': '4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)', 'description': 'nephrotoxicity will be assessed using serum creatinine and blood urea nitrogen.'}, {'measure': 'The occurrence of cisplatin-induced peripheral neuropathy.', 'timeFrame': '4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)', 'description': 'peripheral neuropathy will be assessed using Common terminology criteria for adverse event (CTCAE)'}, {'measure': 'The occurrence of cisplatin-induced peripheral neuropathy.', 'timeFrame': '4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)', 'description': 'peripheral neuropathy will be assessed using The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale'}, {'measure': 'The occurrence of cisplatin-induced peripheral neuropathy.', 'timeFrame': '4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)', 'description': 'peripheral neuropathy will be assessed using DouleurNeuropathique 4 Questions ( dn4 questionnaire)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['N-acetylcysteine', 'Ototoxicity', 'Cisplatin', 'Nephrotoxicity', 'Peripheral neuropathy'], 'conditions': ['Cisplatin Adverse Reaction', 'Cisplatin Nephrotoxicity', 'Cisplatin Induced Peripheral Neuropathy', 'Cancer Patients', 'Cisplatin Ototoxicity']}, 'descriptionModule': {'briefSummary': 'Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients', 'detailedDescription': 'Cisplatin is a clinically advanced and highly effective anticancer drug used in the treatment of a wide variety of malignancies, Cisplatin was the first heavy metal compound to be used as an antineoplastic, and since its approval by the FDA in 1978, it is one of the most widely used agents in cancer therapy .\n\nIt has been used, sole or combined with other chemotherapeutic agents or even in combination with radiotherapy, in the treatment of several types of cancer, such as cancer of the testicles, ovarian, bladder, lung, head and neck, pancreas, breast, endometrium, esophagus, advanced cervical cancer, lymphomas, metastatic osteosarcomas and melanomas.\n\nThe therapeutic effect of cisplatin is significantly increased with dose-escalating, but high-dose therapy is limited by severe toxicities, with nephrotoxicity, neurotoxicity, and ototoxicity being the most important complications. In the case of nephrotoxicity, preventive measures such as saline hydration and osmotic diuresis are employed in clinical practice with minor success.\n\nN-acetylcysteine (NAC) is a thiolic amino acid that has been reported to scavenge free radicals, replenish reduced glutathione (GSH), prevent its depletion, and inhibit lipid peroxidation (LPO). It can also restore the deterioration in the pro-oxidant/antioxidant balance via its metal-chelation activity.\n\nPrevious studies suggest that pre-administration of NAC attenuates carboplatin-induced injury in the cochlea of rats. As a GSH prodrug and antioxidant, NAC may ameliorate cochlear damage through a variety of mechanisms, such as providing a substrate for cochlear GSH synthesis, free radical scavenging, and inhibition of cell death pathway activation and necrosis.\n\nTo date, no clinical trial has been performed to evaluate the preventive potential of oral 1200 mg N-acetylcysteine on cisplatin-induced ototoxicity, hence this trial is designed to examine its effect on ototoxicity, nephrotoxicity, and neurotoxicity in cancer patients treated with cisplatin\n\nBlood samples will be withdrawn from the study patients after enrollment to evaluate each of the following:\n\n1. Complete blood picture (CBC) every cycle\n2. Liver transaminases (AST and ALT) at baseline\n3. Serum creatinine and blood urea nitrogen every cycle\n\nBaseline glomerular filtration rate will be calculated according to the Cockcroft-Gault formula:\n\ncreatinine clearance (ml/min) = (140-age) x body weight plasma creatinine(mg/dl) x 72 The obtained value was multiplied by 0.85 for women.\n\n* Baseline clinical investigations\n\n 1. Audiometric test at baseline and every 2 cycles) patients will undergo conventional pure-tone audiometry in a soundproof room. The pure-tone thresholds for each ear will be measured at frequencies of 250, 500, 1000, 2000, 4000, and 8000 Hz).( bc cancer)\n 2. Common terminology criteria for adverse event (CTCAE) version 4 (BC CANCER)\n 3. The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale.\n* Follow-up and end-of-study evaluation The follow up of the patient will occur at the end of each cycle (after 21 days) and at the end of the study after receiving his or her 4th cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are eligible for inclusion if they meet the following criteria:\n\n * Cancer patients aged \\>18 years receiving cisplatin-containing chemotherapy.\n * A cisplatin dose starting from 75 mg/m2.\n * Various cancer types.\n * Both males and females.\n * No history of organ transplantation or kidney dialysis.\n * Eastern cooperative oncology group performance (ECOG):0-2\n\nExclusion Criteria:\n\n* Patients with peripheral neuropathy.\n* Preexisting unilateral or bilateral moderate to severe sensorineural hearing loss\n* Patients with speech discrimination affection or those who are unable to participate in audiologic evaluation\n* Co-administration of ifosfamide with cisplatin, because of the known risk of nephrotoxicity.\n* Pregnancy or lactation.\n* Infection with the human immunodeficiency virus (HIV).\n* Prior administration of cisplatin.\n* Intraperitoneal chemotherapy.\n* 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).\n* Inadequate renal function (creatinine \\> 1.25 times upper normal limit \\[ULN\\], creatinine clearance \\< 50mL/min).\n* Serious comorbid systemic disorder incompatible with the study (uncontrolled diabetes mellitus or hypertension, myocardial infarction within the last 6 months).\n* Patients diagnosed with kidney cancer.\n* Exposure to any nephrotoxic drugs or agents.'}, 'identificationModule': {'nctId': 'NCT06297369', 'briefTitle': 'Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients', 'orgStudyIdInfo': {'id': 'RHDIRB2020110301 REC #250'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'N acetyl cysteine', 'type': 'DRUG', 'description': 'N-acetylcysteine 600 mg twice daily (acetylcystein ® 600 mg effervescent instant granules sachets, Sedico, Egypt)', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt.', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'mahmoud ibrahim, master', 'role': 'CONTACT', 'email': 'mahmoudibrahim9797@gmail.com', 'phone': '01067803525'}], 'overallOfficials': [{'name': 'mahmoud ibrahim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical pharmacist at ain shams university hospitals', 'investigatorFullName': 'Mahmoud Ibrahim', 'investigatorAffiliation': 'Ain Shams University'}}}}