Hepatocellular CarcinomaNCT06039280
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.
A study testing N Acetylcysteine and Dexamethasone in people with Hepatocellular Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- N Acetylcysteine and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing TACE procedure
- Valid Consent
- Age 18-65 years
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Phool Chand, MD, 01146300000, phoolchand99@gmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- N Acetylcysteine, Dexamethasone, Placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N AcetylcysteineDrug
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.
DexamethasoneDrug
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.
PlaceboOther
The placebo will be administered in the same way as the drug in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: N Acetylcysteine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of post-embolization syndrome
Prevention of Post-embolization syndrome , Defined base on South west oncology group (SWOG) toxic coding less than 2 score
Measured: 72 hours
Secondary outcomes (3)
Prevention of post TACE decompensation at 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.
Measured: 4 weeks
Decrease in the duration of hospitalisation
Measured: 4 weeks
Adverse events of Dexamethasone and NAC in patients undergoing transarterial chemoembolisation for HCC
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039280
- Sponsor's protocol ID
- ILBS-HCC-06
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06039280
- Acronym / sponsor ID
- ILBS-HCC-06
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC+Dexamethasone | Experimental | Drug: N Acetylcysteine, Drug: DexamethasoneNAC 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+Placebo | Active comparator | Drug: N Acetylcysteine, Other: PlaceboNAC 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing TACE procedure
- Valid Consent
- Age 18-65 years
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N AcetylcysteineNAC 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 | NAC+Dexamethasone, NAC+Placebo |
| DexamethasoneDexamethasone 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 | NAC+Dexamethasone |
| PlaceboThe placebo will be administered in the same way as the drug in the experimental group. | Other | NAC+Placebo |
Primary outcome
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
3 secondary outcomes
Prevention of post TACE decompensation at 4 weeks
Time frame: 4 weeks
Decrease in the duration of hospitalisation
Time frame: 4 weeks
Adverse events of Dexamethasone and NAC in patients undergoing transarterial chemoembolisation for HCC
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N Acetylcysteine and Dexamethasone in people with Hepatocellular Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Phool Chand, MD (01146300000, phoolchand99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of post-embolization syndrome (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.