NCT02135887

A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer.

The Purpose of This Study is to Evaluate the Effectiveness of MB-6 as Adjuvant Therapy in Reducing Neutropenia When Given Oxaliplatin-based Chemotherapy in Patients With Stage 3 Colorectal Cancer Previously Treated With Surgery.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 184 (estimated)
• Sponsor: Microbio Co Ltd · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.

Detailed description

The investigational new drug, MB-6, in the proposed clinical trial is to be used as an adjuvant therapy for metastatic colorectal cancer patients. All of six extracts have been used in human with a long history, and many literatures reported the medicinal use either individually or as ingredients of formulations. MB-6 may provide its therapeutic benefits via inhibition of tumor induction or enhancing the efficacy of chemotherapy in colorectal cancer.

Conditions

• Stage III Colorectal Cancer
• Neutropenia

Interventions

Type	Name	Description
DRUG	MB-6	6# TID with meal
DRUG	Placebo	6# TID with meal

Timeline

• Start date: 2013-11-04
• Primary completion: 2022-03-31
• Completion: 2022-12-31
• First posted: 2014-05-12
• Last updated: 2020-12-22

Locations

1 site across 1 country: Taiwan