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MB-6, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks

Placebo, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks

MB-6

Placebo

William Chen, M.D.

Clinical Project Manager

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.

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.

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.

The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)\<500/mm3

To determine the time interval from randomization to the first episode of grade 4 Neutropenia.

The analyses for incidence of study event will be conducted using logistic regression model method to adjust for gender and the regimen of chemotherapy (e.g., FOLFOX4 or FOLFOX6).

The febrile neutropenia is defined as an ANC \<1000/mm3 and a single temperature ≥38.3 degree of C or a sustained temperature of ≥38.0 degree C for more than one hour.

The grade 3 or 4 neutropenia during the chemotherapy period is defined as an absolute neutrophil count (ANC) \<1000/mm3.

Any change in Serum Creatinine level during the chemotherapy period

Health-Related Quality of Life (HRQoL) - QLQ-C30 should be completed at baseline, day 71 and end of study.

Quality of Life -VAS on Fatigue, Constipation, Appetite will be assessed by patients every two weeks until end of study.

The compliance with chemotherapy will be summarized by descriptive statistic and listed by each cycle and overall period.

Any increased body weight during the chemotherapy period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer.	NCT02135887	Stage III Color... Neutropenia	MB-6 Placebo	20 Years - 80 Years	Microbio Co Ltd
A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer.	NCT02135887	Stage III Color... Neutropenia	MB-6 Placebo	20 Years - 80 Years	Microbio Co Ltd

Spots Global Cancer Trial Database for grade 4 neutropenia