Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Syndrome

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Respiratory System Agents

Dexamethasone

Dexamethasone acetate

Acetylcysteine

N-monoacetylcystine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antiviral Agents

Expectorants

Antioxidants

Protective Agents

Antidotes

NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.

Dexamethasone 20 mg in 5 ml NS 1 hour prior to procedure and 8 mg in 5 ml NS at day 2, day 3. Placebo 5 ml NS 1 hr prior to procedure.

NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.

N Acetylcysteine

Dexamethasone 20 mg in 5 ml NS 1 hour prior to procedure and 8 mg in 5 ml NS at day 2, day 3. Placebo 5 ml NS 1 hr prior to procedure.

The placebo will be administered in the same way as the drug in the experimental group.

Placebo

Dr Phool Chand, MD

N-acetylcysteine (NAC), a glutathione precursor and potent antioxidant, is known as a liver protector. As a steroid preparation, dexamethasone is known to have efficient anti-inflammation and immunosuppression effects. N-acetyl cysteine and Dexamethasone's roles in preventing post-embolization syndrome following TACE have each been researched individually in the past. Up until now, no study has been done that has compared dexamethasone and NAC in post-embolization syndrome. With this study, we aim to study the efficacy of combining dexamethasone with N-acetyl cysteine in the prevention of post-embolization syndrome within 72 hours among patients who undergo transarterial chemoembolization for HCC.

Aim \& Objectives Hypothesis: The combination of dexamethasone with NAC is superior to NAC alone in prevention of PES among patients who undergo TACE in HCC as both medications work differently to prevent PES.

AIM:- To study the efficacy of combining Dexamethasone to N acetyl cysteine in prevention of post embolization syndrome within 72 hours among patients who undergo transarterial chemoembolization for HCC.

Objective - PRIMARY Prevention of post embolisation syndrome within 72 hours.

SECONDARY

* Prevention of post embolisation decompensation at 2 weeks.
* Decrease in the duration of hospitalization.
* To study the adverse effects of NAC and steroids in patients who undergo transarterial chemoembolisation for HCC.

Methodology:

Study population:

* All patients undergoing TACE procedure
* Valid Consent
* Age 18-65 years

Study design:

Monocentric open label prospective randomized controlled study. The study will be conducted in Department of Hepatology, ILBS.

Sample size:

* Assuming that NAC prevents PES by 75% and addition of dexamethasone further prevents PES by 20 % (i.e combination of NAC and Dexamethasone prevents total 95%).
* Then with alpha as 5% and power 90 % .we need to enroll total 130 cases i.e 65 in each arm.
* Further assuming 10% drop out , it is decided to enroll 150 cases i.e. 75 in each arm.
* Allocation will be done randomly by block randomization method, taking block size as 10.

Monitoring and assessment: All the parameters of the objective and also noted any adverse effects.

Intervention: TACE.

STATISTICAL ANALYSIS:

The data will be entered in Microsoft excel and will be analyzed using SPSS version 22. The categorical data will be analyzed using Chi square/Fissure test. Exact test and continuous data will be compiled using t-test. Besides this the univariate and multivariate survival analysis will be carried out using Cox regression method. Kaplan-Meier technique will be applied for further analysis. P-value\<0.05 will be considered as significant.

Adverse effects: allergic drug reaction.

Stopping rule: If patient decided to withdraw from study.

Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization.

Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization - Randomized Controlled Trial.

Prevention of Post-embolization syndrome , Defined base on South west oncology group (SWOG) toxic coding less than 2 score

Metric / Method of measurement : Post TACE decompensation defined as an increase in Child-Pugh score of more than two points or newly developed decompensating events, such as ascites, hepatic encephalopathy, or serum total bilirubin \> 2 mg/dL.

Institute of Liver and Biliary Sciences, India

Ear, Nose, and Throat Diseases

Nervous System Diseases

Substance Related Disorders

Wounds and Injuries

Head and Neck Neoplasms

Hearing Loss

Deafness

Ototoxicity

Hearing Disorders

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Neurologic Manifestations

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Cisplatin

Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.

Placebo Oral Tablet

Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial

Hospital San Juan de Dios, Santiago

Otolaryngologist, Clinical Epidemiologist.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Kidney Diseases

Hematologic Neoplasms

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Amphotericin B

Liposomal amphotericin B

amphotericin b (0.5-1.25 mg/kg )over 6-8 hours +NAC 600mg twice daily throughout amphotericin b treatment

amphotericin b (0.5-1.25mg/kg)over 6-8 hours infusion

N-acetylcysteine sachets 600 mg twice daily

yasmin munir, master

When treating individuals with febrile neutropenia, amphotericin B (AmB-d) is one of the most effective treatments against often fatal systemic fungal infections.Nephrotoxicity from amphotericin B can develop with an incidence of up to 80.This emphasizes the value of nephroprotectant agent use.Because of N-acetylcysteine's antioxidant, antiapoptotic, vasodilator properties and its therapeutic effects on contrast nephropathy. Acetylcysteine's impact on amphotericin B-induced nephrotoxicity in cancer patients is assessed.

Severe fungal infections continue to be a significant source of morbidity and mortality in haematology units despite recent therapeutic advancements. The first anti-fungal medication that was successful against systemic mycoses was characterised as the traditional amphotericin B in the middle of the 1950s.AMB remains the treatment of choice for many serious fungal infections in vulnerable hosts owing to its excellent spectrum of activity and its low resistance rates. To date, it continues to be the agent with the widest spectrum of action and the lowest resistance potential of any known antifungal agent.In spite of clinical effectiveness, AmB treatment is associated with a range of acute and chronic adverse reactions . Nephrotoxicity and consequent electrolytes imbalances have been demonstrated as the most clinically significant adverse reaction of AmB that can restrict its clinical utility. Up to 80 % of AmB recipients during the first two weeks of treatment may develop some degree of reversible kidney injury . In addition, nearly 15 % of these patients may require dialysis which can lead to prolongation of hospital stay, increased total treatment costs, and mortality .

N-acetylcysteine, a drug with vasodilating, antiapoptotic, and anti-oxidant features, has been found to diminish the nephrotoxicity of cisplatin , cyclosporine and gentamicin . The results of two experimental studies in rats have suggested that N-acetylcysteine can mitigate GFR reduction as well as renal tubular apoptosis caused by AmB .

Drug Nephrotoxicity Amelioration by N-acetylcysteine

Drug Nephrotoxicity Amelioration in Hematological Malignancies Patients by N-acetylcysteine

minimum of 0.3 mg/dL increase in serum creatinine within 48 hours from amphotericin B initiation.

Hypokalemia and hypomagnesemia were defined as serum potassium levels less than 3 mEq/L and serum magnesium levels less than 1.2 mEq /L, respectively.

Helwan University

Teaching assistant

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization.	NCT06039280	Hepatocellular ...	N Acetylcystein... Dexamethasone Placebo	18 Years - 65 Years	Institute of Liver and Biliary Sciences, India
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer	NCT03400709	Cisplatin Adver... Hearing Loss Ot...	N Acetylcystein... Placebo Oral Ta...	18 Years -	Hospital San Juan de Dios, Santiago
Drug Nephrotoxicity Amelioration by N-acetylcysteine	NCT06122311	Drug-Induced Ne...	N Acetylcystein...	18 Years -	Helwan University
Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization.	NCT06039280	Hepatocellular ...	N Acetylcystein... Dexamethasone Placebo	18 Years - 65 Years	Institute of Liver and Biliary Sciences, India

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