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Trial Title:
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
NCT ID:
NCT06297369
Condition:
Cisplatin Adverse Reaction
Cisplatin Nephrotoxicity
Cisplatin Induced Peripheral Neuropathy
Cancer Patients
Cisplatin Ototoxicity
Conditions: Official terms:
Ototoxicity
Peripheral Nervous System Diseases
Acetylcysteine
N-monoacetylcystine
Conditions: Keywords:
N-acetylcysteine
Ototoxicity
Cisplatin
Nephrotoxicity
Peripheral neuropathy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
N acetyl cysteine
Description:
N-acetylcysteine 600 mg twice daily (acetylcystein ® 600 mg effervescent instant granules
sachets, Sedico, Egypt)
Arm group label:
treatment group
Summary:
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities
in Cancer Patients
Detailed description:
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 .
It 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.
The 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-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.
Previous 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.
To 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
Blood samples will be withdrawn from the study patients after enrollment to evaluate each
of the following:
1. Complete blood picture (CBC) every cycle
2. Liver transaminases (AST and ALT) at baseline
3. Serum creatinine and blood urea nitrogen every cycle
Baseline glomerular filtration rate will be calculated according to the Cockcroft-Gault
formula:
creatinine clearance (ml/min) = (140-age) x body weight plasma creatinine(mg/dl) x 72 The
obtained value was multiplied by 0.85 for women.
- Baseline clinical investigations
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)
2. Common terminology criteria for adverse event (CTCAE) version 4 (BC CANCER)
3. The Functional Assessment of Cancer Therapy/Gynecologic Oncology
Group-Neurotoxicity (FACT/GOG-Ntx) subscale.
- 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt.
Address:
City:
Cairo
Country:
Egypt
Status:
Recruiting
Start date:
February 1, 2024
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06297369