Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297369
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-22
Brief Title:
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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-oxidantantioxidant 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 mlmin 140-age x body weight plasma creatininemgdl x 72 The obtained value was multiplied by 085 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 TherapyGynecologic Oncology Group-Neurotoxicity FACTGOG-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
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-oxidantantioxidant 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 mlmin 140-age x body weight plasma creatininemgdl x 72 The obtained value was multiplied by 085 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 TherapyGynecologic Oncology Group-Neurotoxicity FACTGOG-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None