Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity

Sponsor

Foundation University Islamabad (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06019520

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cisplatin is one of the first-line drugs used against many malignancies, such as lung cancer, head and neck cancer, esophageal cancer, gastric cancer, colorectal cancer, urothelial cancer, bladder cancer and testicular cancer. The usage of Cisplatin is limited by its severe nephrotoxicity, which particularly affects the proximal tubule epithelial cells (PTEC).Several studies suggest role of NAC in ameliorating Cisplatin induced nephrotoxicity, although definitive data is lacking. N-Acetylcysteine (NAC) is a thiol-containing antioxidant, which not only acts as a precursor of glutathione but also as a direct antioxidant .There are multiple postulated mechanisms for NAC's nephroprotection. NAC is a low-cost, easily available drug with a very good safety profile and therefore can be added as a support medication during treatment with cisplatin. The investigators plan to administer 1200 mg oral NAC 12 hours before chemotherapy and then daily at night for the subsequent 6 days, with an objective to ascertain its nephroprotective role in population receiving Cisplatin/-based chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Drug Toxicity	Drug: N-Acetylcysteine Drug: Chemotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

It will be a two-arm study with 35 patients in each arm. After taking informed consent, a total of 70 patients will be enrolled. The patients will be enrolled by convenience nonprobability sampling technique. Then they will be randomized to the N-Acetylcysteine plus chemotherapy and chemotherapy-alone arms.It will be a two-arm study with 35 patients in each arm. After taking informed consent, a total of 70 patients will be enrolled. The patients will be enrolled by convenience nonprobability sampling technique. Then they will be randomized to the N-Acetylcysteine plus chemotherapy and chemotherapy-alone arms.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity

Actual Study Start Date :

Aug 9, 2023

Anticipated Primary Completion Date :

Feb 9, 2024

Anticipated Study Completion Date :

Mar 9, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cisplatin group This group of Patients will receive Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol	Drug: Chemotherapy Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.
Experimental: N-acetylcysteine group Patients in the NAC arm to be given N-acetylcysteine 1200 mg/day starting 12 hrs before till 6 days after Cisplatin-based chemotherapy administration. Hydration according to standard hydration protocol will be given.	Drug: N-Acetylcysteine Patients in the NAC arm will receive1200 mg of NAC (water-soluble granule Preparation) administered orally once daily at night for 7 consecutive days (1 days before chemotherapy, on the day of chemotherapy, and 5 days after chemotherapy) in each cycle of chemotherapy. Drug: Chemotherapy Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.

Arm

Intervention/Treatment

Active Comparator: Cisplatin group

This group of Patients will receive Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol

Drug: Chemotherapy

Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.

Experimental: N-acetylcysteine group

Patients in the NAC arm to be given N-acetylcysteine 1200 mg/day starting 12 hrs before till 6 days after Cisplatin-based chemotherapy administration. Hydration according to standard hydration protocol will be given.

Drug: N-Acetylcysteine

Patients in the NAC arm will receive1200 mg of NAC (water-soluble granule Preparation) administered orally once daily at night for 7 consecutive days (1 days before chemotherapy, on the day of chemotherapy, and 5 days after chemotherapy) in each cycle of chemotherapy.

Drug: Chemotherapy

Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.

Outcome Measures

Primary Outcome Measures

Serum creatinine of participant [18 weeks]
Blood samples collected and measured in laboratory with the unit mg/dL
Creatinine clearance of participant [18 weeks]
It will be calculated using Cockroft-Gault formula , unit ml/min
Estimation of Acute kidney injury to participant [18 weeks]
Acute kidney injury will be assessed by RIFLE criteria that will be calculated for patients
Blood urea nitrogen of participant [18 weeks]
Blood samples collected and measured in laboratory with the unit mg/dl

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult female outpatients with non-hematological malignancies (Breast, ovary and head and neck squamous cell carcinomas)
Having Eastern Cooperative Oncology Group(ECOG) Performance Status ≤2 who had never received platinum based Chemotherapy in past and were now scheduled to receive high-dose cisplatin chemotherapy.
Patients were required to have estimated glomerular filtration rate (GFR)(according to Cockcroft-Gault formula) ≥ 60 ml/min at start of chemotherapy regimen with normal Blood Counts, Liver, and kidney function tests

Exclusion Criteria:

Patients who had poor performance status i.e., ECOG Performance Status 3 or 4
Who declined to participate at any time during the course of the study
Patients having hepatic failure (Liver Function tests >3 times of upper limit normal)
Patients who did not tolerate the use of NAC or were administered the drug <70% of the time
Patient who were receiving concurrent nephrotoxic drugs, or having history of Hypersensitivity to N-Acetyl cysteine.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Oncology department, Fauji Foundation Hospital	Rawalpindi	Punjab	Pakistan	46000

Sponsors and Collaborators

Foundation University Islamabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Foundation University Islamabad

ClinicalTrials.gov Identifier:

NCT06019520

Other Study ID Numbers:

FUI/CTR/2023/14

First Posted:

Aug 31, 2023

Last Update Posted:

Aug 31, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Acetylcysteine

N-monoacetylcystine

Study Results

No Results Posted as of Aug 31, 2023