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

NCT01018381 | Completed

• 1 other identifier: HCC and HBV
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Hepatitis B

Keywords

HCC; HBV; MGN-3; BioBran; Alternative Therapy

Outcome Measures

Primary Outcomes (1)

• Patient survival

  3 years

Secondary Outcomes (1)

• Disease recurrence

  3 years

Study Arms (2)

Conventional Therapy

ACTIVE COMPARATOR

Conventional therapy is given, including PEIT, TOCE, PEIT + TOCE, TOCE + RFA for hepatocellular carcinoma or Entecavir for hepatitis B virus.

Procedure: PEIT; Procedure: TOCE; Procedure: TOCE plus PEIT; Procedure: TOCE plus RFA; Drug: Entecavir

Conventional Therapy plus MGN-3

EXPERIMENTAL

Procedure: PEIT; Procedure: TOCE; Procedure: TOCE plus PEIT; Procedure: TOCE plus RFA; Dietary Supplement: MGN-3; Drug: Entecavir

Interventions

PEIT PROCEDURE

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.

Also known as: Pericutaneous Ethanol Injection Therapy, Pericutaneous Ethanol Injection, PEI

Conventional Therapy; Conventional Therapy plus MGN-3

TOCE PROCEDURE

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.

Also known as: Transarterial oily chemoembolization

Conventional Therapy; Conventional Therapy plus MGN-3

TOCE plus PEIT PROCEDURE

A combination of transarterial oily chemoembolization and pericutaneous ethanol injection therapy are given for patients with HCC.

Also known as: Transarterial oily chemoembolization, Pericutaneous ethanol injection therapy, Pericutaneous ethanol injection

Conventional Therapy; Conventional Therapy plus MGN-3

TOCE plus RFA PROCEDURE

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)

Also known as: Transarterial oily chemoembolization, Radiofrequency ablation

Conventional Therapy; Conventional Therapy plus MGN-3

MGN-3 DIETARY_SUPPLEMENT

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.

Also known as: Peak Immune 4, BioBran, Lentin Plus 1000

Conventional Therapy plus MGN-3

Entecavir DRUG

For patients with hepatitis B viral infection, a dose of 0.5mg/day, every day, was given for a duration of 24 months.

Also known as: Baraclude

Conventional Therapy; Conventional Therapy plus MGN-3

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Used immunotherapy or corticotherapy for 6 months
• Pregnant woman

Sponsors & Collaborators

• The 108 Military Central Hospital: lead
• Charles Drew University of Medicine and Science: collaborator

Study Sites (1)

The 108 Military Central Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis B

Interventions

Radiofrequency Ablation; polysaccharide MGN3; lens intermediate filament proteins; entecavir

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; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Mai Hong Bang, M.D. Ph.D.

  The 108 Military Central Hospital, Hanoi, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 23, 2009
• Study Start: June 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: November 1, 2009
• Last Updated: November 23, 2009

Record last verified: 2009-11

Locations

VN (1)