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

• Conditions: Stage III Colorectal Cancer; Neutropenia
• Interventions: Drug: MB-6; Drug: Placebo

• Registration Number: NCT02135887
• Lead Sponsor: Microbio Co Ltd

Brief 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.

Study Timeline

• Study Start: 2013-11-04
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-20
• Last Update Posted: 2020-12-22
• Primary Completion: 2022-03-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. Men or women 20 years of age or older.
2. Histologically or cytologically confirmed stage 3 colorectal adenocarcinoma.
3. Complete resection of the primary tumor without gross or microscopic evidence of residual disease.
4. No more than 8 weeks have elapsed from the time of surgery and have recovered from the effects.
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) < 2 at the time of screening.
6. Hematological function: ANC≥1500/mm3, Hemoglobin ≥9.0 g/dL, Platelet count ≥100000/mm3.
7. Kidney function:Serum creatinine <2 mg/dL.
8. Liver function: AST ≤3 times ULN, ALT ≤3 times ULN, Total Bilirubin ≤2 times ULN.
9. Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
10. Men and women of childbearing potential must agree to employ adequate contraception during the study period.

Exclusion Criteria

1. History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
2. Systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) administered after surgery and prior to randomization.
3. Concurrent treatment with any other anticancer therapy.
4. Radiotherapy ≤14 days prior to randomization.
5. Any unresolved toxicity > CTC (Common Toxicity Criteria) grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity and alopecia.
6. Patients with congestive heart failure, epilepsy, or other significant medical conditions as judged by the investigator.
7. Contraindications to FOLFOX chemotherapy: peripheral neuropathy NCI CTC >1, liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months before randomization.
8. Patient of child-bearing potential is evidently pregnant or is breast feeding.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MB-6+FOLFOX chemotherapy	MB-6	MB-6, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks
Placebo+FOLFOX chemotherapy	Placebo	Placebo, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3.	18 weeks	The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)\<500/mm3

Secondary Outcome Measures

Name	Time	Method
Health-Related Quality of Life (HRQoL) - QLQ-C30	18 weeks	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	18 weeks	Quality of Life -VAS on Fatigue, Constipation, Appetite will be assessed by patients every two weeks until end of study.
Time to first Grade 4 Neutropenia	18 weeks	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).
Incidence of Febrile Neutropenia	18 weeks	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.
Incidence of Grade 3 or 4 Neutropenia	18 weeks	The grade 3 or 4 neutropenia during the chemotherapy period is defined as an absolute neutrophil count (ANC) \<1000/mm3.
Increase in Body Weight	18 weeks	Any increased body weight during the chemotherapy period.
Change in Serum Creatinine level	18 weeks	Any change in Serum Creatinine level during the chemotherapy period
Compliance with Chemotherapy	18 weeks	The compliance with chemotherapy will be summarized by descriptive statistic and listed by each cycle and overall period.

Trial Locations

Locations (1)

Microbio Co., Ltd.; 🇨🇳 Taipei, Taiwan