Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

Cancer Patients Clinical Trial

Official title: Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

Status Recruiting

Clinical Trial Summary

Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

Clinical Trial 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Blood samples will be withdrawn from the study patients after enrollment to evaluate each of the following: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. ;

Related Conditions & MeSH terms

• Cancer Patients
• Cisplatin Adverse Reaction
• Cisplatin Nephrotoxicity
• Cisplatin Ototoxicity
• Ototoxicity
• Peripheral Nervous System Diseases

• NCT number: NCT06297369
• Study type: Interventional
• Source: Ain Shams University
• Contact: mahmoud ibrahim, master
• Phone: 01067803525
• Email: mahmoudibrahim9797@gmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Completion date: August 1, 2025