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

NACompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

July 31, 2008

Study Completion Date

November 30, 2009

Conditions
Hepatocellular CarcinomaHepatitis B
Interventions
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."

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.

PROCEDURE

TOCE plus PEIT

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

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)

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.

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.

Trial Locations (1)

Unknown

The 108 Military Central Hospital, Hanoi

All Listed Sponsors
collaborator

Charles Drew University of Medicine and Science

OTHER

lead

The 108 Military Central Hospital

OTHER_GOV

NCT01018381 - Arabinoxylan Rice Bran (MGN-3/Biobran) for the Treatment of Hepatocellular Carcinoma and Hepatitis B and C Infection | Biotech Hunter | Biotech Hunter