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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The 108 Military Central Hospital
• Collaborator: Charles Drew University of Medicine and Science
• Treatments: Entecavir; Ethanol

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