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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.

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ClinicalTrials.gov Identifier: NCT06039280
Recruitment Status : Not yet recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: N Acetylcysteine Drug: Dexamethasone Other: Placebo Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : September 15, 2023
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NAC+Dexamethasone

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.

 Drug: N Acetylcysteine
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.

Drug: Dexamethasone
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.
Active Comparator: NAC+Placebo
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.
 Drug: N Acetylcysteine
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.

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


Outcome Measures
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Primary Outcome Measures :
  1. Prevention of post-embolization syndrome [ Time Frame: 72 hours ]
    Prevention of Post-embolization syndrome , Defined base on South west oncology group (SWOG) toxic coding less than 2 score


Secondary Outcome Measures :
  1. Prevention of post TACE decompensation at 4 weeks [ Time Frame: 4 weeks ]
    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.

  2. Decrease in the duration of hospitalisation [ Time Frame: 4 weeks ]
  3. Adverse events of Dexamethasone and NAC in patients undergoing transarterial chemoembolisation for HCC [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Child Pugh C, Child Pugh B > 8
  • HCC patients with a curative therapy (Ablation, Resection or LT)
  • ECOG Performance Status 3-4
  • Pregnancy
  • History of allergic reaction from NAC
  • significant cardiopulmonary disease
  • UGI bleed within last 28 days
  • Recent surgery within last 28 days
  • Documented febrile illness in last 1 weeks
  • Uncontrolled Diabetes (FBS > 200, HBA1C > 8)
  • Uncontrolled Hypertension (BP > 160/100)
  • Structural kidney disease with eGFR < 60 ml/min
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039280


Contacts
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Contact: Dr Phool Chand, MD 01146300000 phoolchand99@gmail.com

Locations
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India
Institute of Liver & Biliary Sciences
New Delhi, Delhi, India, 110070
Contact: Dr Phool Chand, MD    01146300000    phoolchand99@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT06039280    
Other Study ID Numbers: ILBS-HCC-06
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Acetylcysteine
Dexamethasone
N-monoacetylcystine
Anti-Inflammatory Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers