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 | Unknown

• 1 other identifier: ILBS-HCC-06
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Prevention of post-embolization syndrome

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

  72 hours

Secondary Outcomes (3)

• Prevention of post TACE decompensation at 4 weeks

  4 weeks

• Decrease in the duration of hospitalisation

  4 weeks

• Adverse events of Dexamethasone and NAC in patients undergoing transarterial chemoembolisation for HCC

  2 weeks

Study Arms (2)

NAC+Dexamethasone

EXPERIMENTAL

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; Drug: Dexamethasone

NAC+Placebo

ACTIVE COMPARATOR

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; Other: Placebo

Interventions

N Acetylcysteine DRUG

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.

NAC+Dexamethasone; NAC+Placebo

Dexamethasone DRUG

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+Dexamethasone

Placebo OTHER

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

NAC+Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Acetylcysteine; Dexamethasone

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Dr Phool Chand, MD

CONTACT

01146300000; phoolchand99@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: September 15, 2023
• Study Start: September 15, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)