Arabinoxylan Rice Bran (MGN-3/Biobran) for the Treatment of Hepatocellular Carcinoma and Hepatitis B and C Infection

This study has been completed.
Sponsor:
Collaborator:
Charles Drew University of Medicine and Science
Information provided by:
The 108 Military Central Hospital
ClinicalTrials.gov Identifier:
NCT01018381
First received: November 20, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide with an estimated 626,000 new cases per year worldwide, accounting for 5.7% of new cancer cases. Although resection and transplantation offer the best 5-year survival rates, not all patients are suitable surgery candidates. Other treatments include pericutaneous ethanol injection (PEI), radiofrequency ablation (RFA), and transarterial oily chemoembolization (TOCE), all of which enhance the survival rate and aid in shrinkage of the tumor. The very low survival rate among HCC patients, 3-5%, reflects the inadequacy of conventional therapies for the disease and highlights the necessity of finding new treatments or modifying the current treatment.

The hepatitis B virus (HBV) causes liver disease that can range in severity from a mild illness that lasts several weeks (acute hepatitis B) to a long-term chronic illness. An estimated 2 billion people have been infected with HBV worldwide, resulting in more than 350 million individuals with chronic, long-term liver infections. Patients with chronic HBV infection are at a great risk for the development of cirrhosis, hepatic failure, and HCC. There is no cure for hepatitis B and care is mostly palliative. There are several anti-viral and interferon drugs, such as Entecavir and Interferon α therapy, which can help some patients. However, these drugs are costly, thousands of dollars per year, and are not widely available in many countries, especially in the developing world. Vaccination is available and effective and is recommended for all individuals at risk for HBV infection. However, vaccination is only effective in individuals who have not been exposed to HBV. Hepatitis B is closely linked to liver cancer, which is almost always fatal.

MGN-3/Biobran is an arabinoxylan extracted from rice bran that is treated enzymatically with an extract from Shiitake mushrooms. MGN-3 demonstrated anti-cancer activity in vivo in mice and humans. The present study was carried out to examine whether combining the current conventional treatment with a food supplement, arabinoxylan rice bran (MGN-3/Biobran), may improve the outcome of the disease and increase the survival rate of patients with HCC or HBV. We hypothesize that a combinatory treatment of conventional therapy with MGN-3/Biobran will augment the therapeutic effect seen when patients are treated with conventional therapy alone.


Condition Intervention
Hepatocellular Carcinoma
Hepatitis B
Procedure: PEIT
Procedure: TOCE
Procedure: TOCE plus PEIT
Procedure: TOCE plus RFA
Dietary Supplement: MGN-3
Drug: Entecavir

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Study of Arabinoxylan Rice Bran (MGN-3/Biobran) for the Treatment of Hepatocellular Carcinoma and Hepatitis B and C Infection

Resource links provided by NLM:


Further study details as provided by The 108 Military Central Hospital:

Primary Outcome Measures:
  • Patient survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: June 2006
Study Completion Date: November 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Therapy
Conventional therapy is given, including PEIT, TOCE, PEIT + TOCE, TOCE + RFA for hepatocellular carcinoma or Entecavir for hepatitis B virus.
Procedure: PEIT

For patients with HCC: Ethanol (99.5%) 3-15 ml/treatment(mean 8ml/treatment) , 2 times/week (mean 6 treatment/patient). For patients with a tumor size under 5 cm in diameter, we applied the formula of M. Ebara: V = 4/3∏ (r+0.5)3 (V: total Ethanol volume, r: radius of tumor).

Precise treatment was dependent on tumor size, outcomes after first PEIT treatment and time to recurrence of disease.

Other Names:
  • Pericutaneous Ethanol Injection Therapy
  • Pericutaneous Ethanol Injection
  • PEI
Procedure: TOCE
For patients with HCC: Adriamycine was mixed with lipiodol, Adriamycine 20-60mg/treatment (mean 40mg/treatment),lipiodol 5-20ml/treatment(mean 12ml/treatment), 1-2 months between treatments, 2-5 treatments/patient (mean 3 times/patient), which depended on tumor size, outcomes after first TOCE and time to recurrence of disease.
Other Name: Transarterial oily chemoembolization
Procedure: TOCE plus PEIT
A combination of transarterial oily chemoembolization and pericutaneous ethanol injection therapy are given for patients with HCC.
Other Names:
  • Transarterial oily chemoembolization
  • Pericutaneous ethanol injection therapy
  • Pericutaneous ethanol injection
Procedure: TOCE plus RFA
For patients with HCC: A combination of transarterial oily chemoembolization plus radiofrequency ablation is given. For RFA: On mission 60w/s , 5minutes/circle, 2-4 circles/treatment, 1-2 treatments/week (tumor size under 2cm: 1 treatment; 2-4 cm: 2-3 treatments,over 4 cm: 3-5 treatments)
Other Names:
  • Transarterial oily chemoembolization
  • Radiofrequency ablation
Drug: Entecavir
For patients with hepatitis B viral infection, a dose of 0.5mg/day, every day, was given for a duration of 24 months.
Other Name: Baraclude
Experimental: Conventional Therapy plus MGN-3 Procedure: PEIT

For patients with HCC: Ethanol (99.5%) 3-15 ml/treatment(mean 8ml/treatment) , 2 times/week (mean 6 treatment/patient). For patients with a tumor size under 5 cm in diameter, we applied the formula of M. Ebara: V = 4/3∏ (r+0.5)3 (V: total Ethanol volume, r: radius of tumor).

Precise treatment was dependent on tumor size, outcomes after first PEIT treatment and time to recurrence of disease.

Other Names:
  • Pericutaneous Ethanol Injection Therapy
  • Pericutaneous Ethanol Injection
  • PEI
Procedure: TOCE
For patients with HCC: Adriamycine was mixed with lipiodol, Adriamycine 20-60mg/treatment (mean 40mg/treatment),lipiodol 5-20ml/treatment(mean 12ml/treatment), 1-2 months between treatments, 2-5 treatments/patient (mean 3 times/patient), which depended on tumor size, outcomes after first TOCE and time to recurrence of disease.
Other Name: Transarterial oily chemoembolization
Procedure: TOCE plus PEIT
A combination of transarterial oily chemoembolization and pericutaneous ethanol injection therapy are given for patients with HCC.
Other Names:
  • Transarterial oily chemoembolization
  • Pericutaneous ethanol injection therapy
  • Pericutaneous ethanol injection
Procedure: TOCE plus RFA
For patients with HCC: A combination of transarterial oily chemoembolization plus radiofrequency ablation is given. For RFA: On mission 60w/s , 5minutes/circle, 2-4 circles/treatment, 1-2 treatments/week (tumor size under 2cm: 1 treatment; 2-4 cm: 2-3 treatments,over 4 cm: 3-5 treatments)
Other Names:
  • Transarterial oily chemoembolization
  • Radiofrequency ablation
Dietary Supplement: MGN-3
For patients with HCC or hepatitis B, arabinoxylan rice bran food supplement is given. 1 gram per day, every day, for a duration of 12 months. For the MGN-3 group, the interventional therapy was given with MGN-3 simultaneously.
Other Names:
  • Peak Immune 4
  • BioBran
  • Lentin Plus 1000
Drug: Entecavir
For patients with hepatitis B viral infection, a dose of 0.5mg/day, every day, was given for a duration of 24 months.
Other Name: Baraclude

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

HCC patient Criteria of inclusion

  • Patient had ≤3 tumors (1 tumor under 12cm/ or 2 tumor under 5cm /or 3 tumor under 3cm)
  • Stage of disease: Okuda I,II and Child Pugh A,B
  • Liver biopsy: HCC positive
  • General condition: average/ good

Chronic hepatitis B patient Criteria of inclusion

  • Patient have been carrying HBsAg over 6 months
  • ALT was over or equal 2 times ULN
  • HBV-DNA level: 104 (log10 copies/ml) with HBeAg(-) patient and 105 (log10 copies/ml) with HBeAg(+) patient

Exclusion criteria:

HCC patient Criteria of exclusion

  • Tumor size is too big (over 12 cm), multiple tumors (over 3 tumors or diffuse tumor type)
  • Prothrombin under 60%
  • Severe liver or/ and renal insufficiency
  • Portal vein body thrombosis

Chronic hepatitis B patient Criteria of exclusion

  • Used immunotherapy or corticotherapy for 6 months
  • Pregnant woman
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018381

Locations
Vietnam
The 108 Military Central Hospital
Hanoi, Vietnam
Sponsors and Collaborators
The 108 Military Central Hospital
Charles Drew University of Medicine and Science
Investigators
Principal Investigator: Mai Hong Bang, M.D. Ph.D. The 108 Military Central Hospital, Hanoi, Vietnam
  More Information

No publications provided

Responsible Party: Mai Hong Bang, M.D. Ph.D., The 108 Military Central Hospital
ClinicalTrials.gov Identifier: NCT01018381     History of Changes
Other Study ID Numbers: HCC and HBV
Study First Received: November 20, 2009
Last Updated: November 20, 2009
Health Authority: Vietnam: Ministry of Health
United States: Institutional Review Board

Keywords provided by The 108 Military Central Hospital:
HCC
HBV
MGN-3
BioBran
Alternative Therapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Hepatitis
Hepatitis A
Hepatitis B
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Entecavir
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Antiviral Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014