A Phase 2 interventional study of N acetyl cysteine in Cisplatin Adverse Reaction, Cisplatin Nephrotoxicity and Cisplatin Induced Peripheral Neuropathy, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Ain Shams University · Phase 2, Interventional, and Prevention
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
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:
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
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's planned enrollment of 60 is above the median of 47 across 33 interventional studies indexed under Ototoxicity.
Browse Ototoxicity studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients are eligible for inclusion if they meet the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
N-acetylcysteine 600 mg twice daily (acetylcystein ® 600 mg effervescent instant granules sachets, Sedico, Egypt)
The occurrence of cisplatin-induced ototoxicity in the form of hearing loss.
hearing loss will be assessed using audiometry
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 nephrotoxicity.
nephrotoxicity will be assessed using serum creatinine and blood urea nitrogen.
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.
peripheral neuropathy will be assessed using Common terminology criteria for adverse event (CTCAE)
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.
peripheral neuropathy will be assessed using The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale
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.
peripheral neuropathy will be assessed using DouleurNeuropathique 4 Questions ( dn4 questionnaire)
Time frame: 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)
Started Feb 2024 (actual). Primary completion is estimated for Feb 2025, 12 months after the start.
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Studies of the drug tested here: Acetylcysteine