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CTRI Number  CTRI/2024/03/063853 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare steroid versus N-acetyl cysteine to reduce complication after liver tumor directed vascular treatment 
Scientific Title of Study   Dexamethasone versus N-acetylcysteine for the reduction of post-embolization syndrome following trans-arterial chemoembolization for Hepatocellular Carcinoma: a randomized controlled trial (DANCES trial- DexAmethasone versus NAC for Post-Embolization Syndrome) 
Trial Acronym  DANCE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anshuman 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Gastroenteology, National Cancer Institute
All India Institute of Medical Sciences
South
DELHI
110029
India 
Phone  8587935706  
Fax    
Email  anshu27790@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anshuman 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Gastroenteology, National Cancer Institute
All India Institute of Medical Sciences

DELHI
110029
India 
Phone  8587935706  
Fax    
Email  anshu27790@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anshuman 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Gastroenteology, National Cancer Institute
All India Institute of Medical Sciences

DELHI
110029
India 
Phone  8587935706  
Fax    
Email  anshu27790@gmail.com  
 
Source of Monetary or Material Support  
AIIMS 
 
Primary Sponsor  
Name  AIIMS 
Address  National Cancer Institute department of Gastroenterology 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anshuman  All India Institute of Medical Sciences  Department of Gastroenterology, Room No 3111, 3rd floor, Academic Block
South
DELHI 		 8587935706

anshu27790@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexamethasone  Dexamethasone will be given intravenously in a dose of 20 mg before the procedure on day 1 and will be continued in a dose of 8mg per day for two days post procedure 
Comparator Agent  N-acetylcysteine  NAC will be administered in a dose of 150 mg per kg per h for 1 h followed by 12.5 mg per kg per h for 4 h prior to TACE and then a continuous infusion 6.25 mg per h for 48 h after the procedure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All consecutive patients presenting to the Liver Clinic of the Department of Gastroenterology
and Human Nutrition, with cirrhosis and HCC in BCLC stages A-C who are being considered for
TACE will be screened for inclusion and will be included after informed consent 
 
ExclusionCriteria 
Details  1. Allergy to contrast media
2. Main portal vein tumor thrombosis (PVTT)-VP4
3. Extrahepatic disease extension of HCC
4. Child Turcotte Pugh score greater than 9
5. Renal failure
6. Those already on steroids for any other disease e.g. autoimmune hepatitis
7. Active bacterial infection at the time of randomization
8. Bilirubin greater than 3 mg per dL
9. Pregnancy
10. Age less than 18 years 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the proportion of patients developing PES in both groups. PES will be defined as presence of pain and or fever with an increase in the alanine aminotransferase
(ALT) greater than 3X baseline value within 48 hrs after the procedure 		 48 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes will be the proportions of patients developing PTD in both groups.
Any development of new or worsening ascites, encephalopathy, gastrointestinal bleeding and
increase in bilirubin by 2 mg per dL within one week of TACE. The proportion of patients with fever, nausea, vomiting, pain, ALT greater than 3X baseline will also be compared among both groups. Any side effects or complications related to the intervention used will also be reported. 		 7 days 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   20/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/03/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Hepatocellular cancer (HCC) is the most common primary liver cancer and is the fifth leading cause of cancer in males worldwide and the second most common cause of mortality from cancers.The therapeutic landscape of HCC has undergone a paradigm shift with the addition of newer therapies like immune check-point inhibitors (ICI), stereotactic body radiotherapy (SBRT), newer tyrosine kinase inhibitors and expanding role of liver transplantation even for those with end-stage liver disease.  Transarterial chemoembolization (TACE) is one of the components of the therapeutic armamentarium against HCC, which has stood the test of time with an expanding indication to include patients with unresectable HCC (uHCC) mainly in Barcelona Clinic Liver Cancer
(BCLC)- stage B and C. It involves the delivery of chemotherapeutic drug intra-arterially into the arterial branch feeding the tumor followed by embolization which causes increased retention of the chemotherapeutic agent as well as ischemic necrosis of the tumor tissue. Due to this inherent mechanism of action, TACE may be associated with post-embolization syndrome (PES), characterized by pain, fever and/or nausea/vomiting associated with a rise in liver enzymes. This PES may occur in up to 50%-80% of patients and is a predictor of poor outcomes with a two-fold mortality among those who develop it compared to those without PES.5 Female gender, large tumor size, high bilirubin and presence of ascites have been shown to be predictors of PES.6 Post-TACE decompensation (PTD) may also develop in up to one-fifth of the patients and is associated with poor outcomes.7 The underlying mechanism driving the decompensation and PES have been believed to be a hyperinflammatory response driven by the release of danger associated molecular patterns (DAMPs) and reactive oxygen species from the necrotic tumor cells and adjacent liver parenchyma.4 In view of PES and PTD being significant problems, a number of therapies have been tested for their prophylaxis. A couple of randomized controlled trials (RCTs) have shown that prophylactic dexamethasone either in a single dose of 10mg given before the procedure8 or 20 mg on day 1 followed by 8 mg on the following two days9 significantly reduces the incidence of PES.
However, the development of PTD has not been evaluated in these trials. Another RCT has evaluated the antioxidant and glutathione precursor N-Acetyl cysteine (NAC) in a dose of 150 mg/ kg/h for 1 h followed by 12.5 mg/kg/h for 4 h prior to TACE and then continuous infusion 6.25 mg/h for 48 h after the procedure for PES and PTD prophylaxis.10 Although it showed a significant reduction in PES with NAC, there was no difference in PTD incidence between the two groups. Another recent study has evaluated the benefit of the combination of NAC and dexamethasone in reducing PES and PTD following TACE. It remains to be seen whether dexamethasone alone can prevent PTD and how it compares to NAC in terms of preventing PES. In this RCT, we aim to compare the efficacy of NAC versus dexamethasone prophylaxis for prevention of PES and PTD to fill this lacuna.
 
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