Cisplatin Adverse ReactionPhase 2NCT06297369
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
A Phase 2 study testing N acetyl cysteine in people with Cisplatin Adverse Reaction and Cisplatin Nephrotoxicity, run by Ain Shams University at 1 site in Egypt.
Trial summary
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cisplatin Adverse Reaction, Cisplatin Nephrotoxicity, Cisplatin Induced Peripheral Neuropathy
- What is being tested?
- N acetyl cysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Aug 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt.
Cairo
About this study
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Read the 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:
- Complete blood picture (CBC) every cycle
- Liver transaminases (AST and ALT) at baseline
- 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
- 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)
- Common terminology criteria for adverse event (CTCAE) version 4 (BC CANCER)
- 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.
- Conditions
- Cisplatin Adverse Reaction, Cisplatin Nephrotoxicity, Cisplatin Induced Peripheral Neuropathy, Cancer Patients, Cisplatin Ototoxicity
- Being tested
- N acetyl cysteine
- Keywords
- N-acetylcysteine, Ototoxicity, Cisplatin, Nephrotoxicity, Peripheral neuropathy
- Medical subject headings
- Ototoxicity, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N acetyl cysteineDrug
N-acetylcysteine 600 mg twice daily (acetylcystein ® 600 mg effervescent instant granules sachets, Sedico, Egypt)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: N acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of cisplatin-induced ototoxicity in the form of hearing loss.
hearing loss will be assessed using audiometry
Measured: 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.
nephrotoxicity will be assessed using serum creatinine and blood urea nitrogen.
Measured: 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.
peripheral neuropathy will be assessed using Common terminology criteria for adverse event (CTCAE)
Measured: 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.
peripheral neuropathy will be assessed using The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale
Measured: 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.
peripheral neuropathy will be assessed using DouleurNeuropathique 4 Questions ( dn4 questionnaire)
Measured: 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cisplatin Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ibrahim, Ain Shams University
- Investigators
- mahmoud ibrahim, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297369
- Sponsor's protocol ID
- RHDIRB2020110301 REC #250
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
- ClinicalTrials.gov ID
- NCT06297369
- Acronym / sponsor ID
- RHDIRB2020110301 REC #250
- Conditions
- Cisplatin Adverse Reaction, Cisplatin Nephrotoxicity, Cisplatin Induced Peripheral Neuropathy, Cancer Patients, Cisplatin Ototoxicity
- Keywords
- N-acetylcysteine, Ototoxicity, Cisplatin, Nephrotoxicity, Peripheral neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 7 Mar 2024 (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.
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:
- Complete blood picture (CBC) every cycle
- Liver transaminases (AST and ALT) at baseline
- 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
- 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)
- Common terminology criteria for adverse event (CTCAE) version 4 (BC CANCER)
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: N acetyl cysteineb. 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients are eligible for inclusion if they meet the following criteria:
Key exclusion criteria (13 listed)
- 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.
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 acetyl cysteineN-acetylcysteine 600 mg twice daily (acetylcystein ® 600 mg effervescent instant granules sachets, Sedico, Egypt) | Drug | treatment group |
Primary outcome
The occurrence of cisplatin-induced ototoxicity in the form of hearing loss.
Time frame: 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)
hearing loss will be assessed using audiometry
4 secondary outcomes
The occurrence of cisplatin-induced nephrotoxicity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
Related trials for Cisplatin Adverse Reaction
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
Not yet recruitingPhase 1
Safety Study of GMDTC Injection in Participants With Solid Tumors and Cisplatin-Induced Renal Dysfunction
Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
RecruitingObservational study
Association Between Tinnitus and Hearing Loss in Locally Advanced Head and Neck Cancer Treated by Radiotherapy Alone or With Chemotherapy: a Prospective and Multicenter Study
Head Cancer, Neck Cancer
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.
mahmoud ibrahim principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N acetyl cysteine in people with Cisplatin Adverse Reaction and Cisplatin Nephrotoxicity, run by Ain Shams University at 1 site in Egypt.
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 7 inclusion and 13 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 7 Mar 2024. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact mahmoud ibrahim, master (01067803525, mahmoudibrahim9797@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of cisplatin-induced ototoxicity in the form of hearing loss. (time frame: 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)). 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 7 Mar 2024.