Cancer Patients Clinical Trial
Official title:
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 1, 2025 |
Est. primary completion date | February 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt. | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The occurrence of cisplatin-induced ototoxicity in the form of hearing loss. | hearing loss will be assessed using audiometry | 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated) | |
Secondary | The occurrence of cisplatin-induced nephrotoxicity. | nephrotoxicity will be assessed using serum creatinine and blood urea nitrogen. | 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated) | |
Secondary | The occurrence of cisplatin-induced peripheral neuropathy. | peripheral neuropathy will be assessed using Common terminology criteria for adverse event (CTCAE) | 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated) | |
Secondary | The occurrence of cisplatin-induced peripheral neuropathy. | peripheral neuropathy will be assessed using The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale | 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated) | |
Secondary | The occurrence of cisplatin-induced peripheral neuropathy. | peripheral neuropathy will be assessed using DouleurNeuropathique 4 Questions ( dn4 questionnaire) | 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03707548 -
BPT to Improve Bodily Disturbances in Post-treatment Cancer Patients
|
N/A | |
Not yet recruiting |
NCT06463782 -
Clinical Study of 68Ga-LNC1007 Injection PET/CT
|
Phase 1 | |
Not yet recruiting |
NCT04493450 -
NEMO - an App for Side Effect Management in Oncology
|
||
Completed |
NCT05604820 -
The Effect of Progressive Muscle Relaxation Exercise on Sleep Quality
|
N/A | |
Completed |
NCT04024748 -
Verification of Imaging System PCD-1000A
|
||
Completed |
NCT03320161 -
A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project
|
||
Recruiting |
NCT05547282 -
Low-dose Radiotherapy Combined With Conventional Radiotherapy After Immunotherapy Failure
|
N/A | |
Recruiting |
NCT01742143 -
Impact of ICCAN on Cancer Treatment Completion and Quality of Life
|
||
Completed |
NCT05368116 -
Effectiveness of Video Assisted Self Management Program on Chemotherapy Related Side Effects .
|
N/A | |
Recruiting |
NCT01603316 -
Food: A Three-Arm Study Examining Food Insecurity Interventions
|
Phase 2 | |
Recruiting |
NCT03100071 -
Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients
|
||
Completed |
NCT04037410 -
Environmental Temperature and White Adipose Tissue in Cancer Patients
|
||
Recruiting |
NCT06305741 -
A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers
|
N/A | |
Recruiting |
NCT05279378 -
Correlation of Lung Ultrasonography With Chest CT Findings in Cancer Patients With COVID-19 Viral Pneumonia
|
||
Completed |
NCT03536702 -
Effect of Group Led Creative Writing on Mood in Cancer Patients
|
N/A | |
Not yet recruiting |
NCT05922423 -
Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence
|
N/A | |
Completed |
NCT01704469 -
A Comparison of the Perception of a Needle Injection Pain Between Cancer Patients Receiving Opioid Therapy Versus Opioid-naive Patients
|
N/A | |
Active, not recruiting |
NCT06348940 -
Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients
|
N/A | |
Completed |
NCT04302792 -
New Food Solutions for Cancer Patients
|
N/A | |
Recruiting |
NCT05219851 -
The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors
|