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.
Study Type
OBSERVATIONAL
Enrollment
184
Microbio Co., Ltd.
Taipei, Taiwan
RECRUITINGThe primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3.
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)\<500/mm3
Time frame: 18 weeks
Time to first Grade 4 Neutropenia
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).
Time frame: 18 weeks
Incidence of Febrile Neutropenia
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.
Time frame: 18 weeks
Incidence of Grade 3 or 4 Neutropenia
The grade 3 or 4 neutropenia during the chemotherapy period is defined as an absolute neutrophil count (ANC) \<1000/mm3.
Time frame: 18 weeks
Change in Serum Creatinine level
Any change in Serum Creatinine level during the chemotherapy period
Time frame: 18 weeks
Health-Related Quality of Life (HRQoL) - QLQ-C30
Health-Related Quality of Life (HRQoL) - QLQ-C30 should be completed at baseline, day 71 and end of study.
Time frame: 18 weeks
Quality of Life -VAS on Fatigue, Constipation, Appetite
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Quality of Life -VAS on Fatigue, Constipation, Appetite will be assessed by patients every two weeks until end of study.
Time frame: 18 weeks
Compliance with Chemotherapy
The compliance with chemotherapy will be summarized by descriptive statistic and listed by each cycle and overall period.
Time frame: 18 weeks
Increase in Body Weight
Any increased body weight during the chemotherapy period.
Time frame: 18 weeks