Drug ToxicityNCT06019520
Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity
A study testing N-Acetylcysteine and Chemotherapy in people with Drug Toxicity, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Drug Toxicity
- What is being tested?
- N-Acetylcysteine and Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Aug 2023to 9 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Medical Oncology department, Fauji Foundation Hospital
Rawalpindi, Punjab Province, 46000
About this study
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.
- Conditions
- Drug Toxicity
- Being tested
- N-Acetylcysteine, Chemotherapy
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDrug
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.
ChemotherapyDrug
Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin group | Active comparator | This group of Patients will receive Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol Receives: Drug: Chemotherapy |
| N-acetylcysteine group | Experimental | 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. Receives: Drug: N-Acetylcysteine; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine of participant
Blood samples collected and measured in laboratory with the unit mg/dL
Measured: 18 weeks
Creatinine clearance of participant
It will be calculated using Cockroft-Gault formula , unit ml/min
Measured: 18 weeks
Estimation of Acute kidney injury to participant
Acute kidney injury will be assessed by RIFLE criteria that will be calculated for patients
Measured: 18 weeks
Blood urea nitrogen of participant
Blood samples collected and measured in laboratory with the unit mg/dl
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start9 Aug 2023
- Primary completion9 Feb 2024 (estimated)
- Study completion9 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ToxicityStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019520
- Sponsor's protocol ID
- FUI/CTR/2023/14
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity
- ClinicalTrials.gov ID
- NCT06019520
- Acronym / sponsor ID
- FUI/CTR/2023/14
- Conditions
- Drug Toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 9 Feb 2024 (estimated)
- Study completion
- 9 Mar 2024 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cisplatin group | Active comparator | Drug: ChemotherapyThis group of Patients will receive Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol |
| N-acetylcysteine group | Experimental | Drug: N-Acetylcysteine, Drug: ChemotherapyPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-AcetylcysteinePatients 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 | N-acetylcysteine group |
| ChemotherapyCisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol. | Drug | Cisplatin group, N-acetylcysteine group |
Primary outcome
Serum creatinine of participant
Time frame: 18 weeks
Blood samples collected and measured in laboratory with the unit mg/dL
Creatinine clearance of participant
Time frame: 18 weeks
It will be calculated using Cockroft-Gault formula , unit ml/min
Estimation of Acute kidney injury to participant
Time frame: 18 weeks
Acute kidney injury will be assessed by RIFLE criteria that will be calculated for patients
Blood urea nitrogen of participant
Time frame: 18 weeks
Blood samples collected and measured in laboratory with the unit mg/dl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-Acetylcysteine and Chemotherapy in people with Drug Toxicity, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine of participant (time frame: 18 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.