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

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ClinicalTrials.gov Identifier: NCT02135887
Recruitment Status : Recruiting
First Posted : May 12, 2014
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Microbio Co Ltd

Tracking Information
First Submitted Date May 6, 2014
First Posted Date May 12, 2014
Last Update Posted Date December 22, 2020
Actual Study Start Date November 4, 2013
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2018)
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3. [ Time Frame: 18 weeks ]
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)<500/mm3
Original Primary Outcome Measures
 (submitted: May 8, 2014)
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3. [ Time Frame: 18 weeks ]
Change History
Current Secondary Outcome Measures
 (submitted: March 26, 2018)
  • Time to first Grade 4 Neutropenia [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 18 weeks ]
    The grade 3 or 4 neutropenia during the chemotherapy period is defined as an absolute neutrophil count (ANC) <1000/mm3.
  • Change in Serum Creatinine level [ Time Frame: 18 weeks ]
    Any change in Serum Creatinine level during the chemotherapy period
  • Health-Related Quality of Life (HRQoL) - QLQ-C30 [ Time Frame: 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 [ Time Frame: 18 weeks ]
    Quality of Life -VAS on Fatigue, Constipation, Appetite will be assessed by patients every two weeks until end of study.
  • Compliance with Chemotherapy [ Time Frame: 18 weeks ]
    The compliance with chemotherapy will be summarized by descriptive statistic and listed by each cycle and overall period.
  • Increase in Body Weight [ Time Frame: 18 weeks ]
    Any increased body weight during the chemotherapy period.
Original Secondary Outcome Measures
 (submitted: May 8, 2014)
  • Time to first Grade 4 Neutropenia [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 18 weeks ]
    The grade 3 or 4 neutropenia during the chemotherapy period is defined as an absolute neutrophil count (ANC) <1000/mm3.
  • Change in Serum Creatinine level [ Time Frame: 18 weeks ]
  • Health-Related Quality of Life (HRQoL) - QLQ-C30 [ Time Frame: 18 weeks ]
  • Quality of Life -VAS on Fatigue, Constipation, Appetite [ Time Frame: 18 weeks ]
  • Compliance with Chemotherapy [ Time Frame: 18 weeks ]
  • Increase in Body Weight [ Time Frame: 18 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer.
Official Title 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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population A total of 184 patients with stage III colorectal cancer underwent surgery will be recruited into the study for receiving adjuvant therapy over 18 weeks.
Condition
  • Stage III Colorectal Cancer
  • Neutropenia
Intervention
  • Drug: MB-6
    6# TID with meal
    Other Name: Folinic acid; Fluorouracil ; Oxaliplatin
  • Drug: Placebo
    6# TID with meal
    Other Name: Folinic acid; Fluorouracil ; Oxaliplatin
Study Groups/Cohorts
  • MB-6+FOLFOX chemotherapy
    MB-6, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks
    Intervention: Drug: MB-6
  • Placebo+FOLFOX chemotherapy
    Placebo, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 8, 2014)
184
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: William Chen, M.D. 886-4-22052121 ext 1638 wtchen@mail.cmuh.org.tw
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02135887
Other Study ID Numbers MB104CLCT02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Microbio Co Ltd
Study Sponsor Microbio Co Ltd
Collaborators Not Provided
Investigators
Principal Investigator: William Chen, M.D. China Medical University Hospital
PRS Account Microbio Co Ltd
Verification Date December 2020