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

NCT06297369 | Recruiting Phase 2

• 1 other identifier: RHDIRB2020110301 REC #250
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cisplatin Adverse Reaction; Cisplatin Nephrotoxicity; Cisplatin Induced Peripheral Neuropathy; Cancer Patients; Cisplatin Ototoxicity

Keywords

N-acetylcysteine; Ototoxicity; Cisplatin; Nephrotoxicity; Peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The occurrence of cisplatin-induced nephrotoxicity.

  4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)

• The occurrence of cisplatin-induced peripheral neuropathy.

  4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)

• The occurrence of cisplatin-induced peripheral neuropathy.

  4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)

• The occurrence of cisplatin-induced peripheral neuropathy.

  4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)

Study Arms (2)

control group

NO INTERVENTION

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)

treatment group

ACTIVE COMPARATOR

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)

Drug: N acetyl cysteine

Interventions

N acetyl cysteine DRUG

N-acetylcysteine 600 mg twice daily (acetylcystein ® 600 mg effervescent instant granules sachets, Sedico, Egypt)

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt.

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Ototoxicity; Peripheral Nervous System Diseases

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• mahmoud ibrahim

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mahmoud ibrahim, master

CONTACT

01067803525; mahmoudibrahim9797@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist at ain shams university hospitals

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 7, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-02

Locations

EG (1)