The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Silymarin
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring CPT-11(irinotecan), silymarin, GI toxicity
Eligibility Criteria
Inclusion Criteria:
- The patient who is between 20 to 80 years old
- The patient who is diagnosed metastatic colorectal cancer and received chemotherapy with FOLFIRI regimen
- The female patient should not be pregnant or breast-feeding
- The patient who has no severe co-morbidity, such as cardiovascular, cerebrovascular, malignant hypertension, renal and hepatobiliary disease.
- The patient who has no associated drug allergy to this trial.
- The patient who is in compliance with prescribed medication.
- The patient who is willing to sign the permit of the clinical trial.
Exclusion Criteria:
- The patients who do not meet the main inclusion criteria or are not willing to sign the permit.
- The patient who has viral hepatitis or carrier with impaired liver function.
Sites / Locations
- Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
prescription of silymarin
control
Arm Description
During six cycles of FOLFIRI chemotherapy, the patients will take silymarin (150mg) three times daily from day 1 to day 7 during one cycle of treatment.
During six cycles of FOLFIRI chemotherapy, the patients will not take silymarin during chemotherapy
Outcomes
Primary Outcome Measures
GI associated adverse events
Response rate and grades of GI associated adverse events (AEs) according to the Response Evaluation Criteria in Solid Tumors (version 1.1)
Secondary Outcome Measures
Full Information
NCT ID
NCT03130634
First Posted
April 22, 2017
Last Updated
May 11, 2020
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03130634
Brief Title
The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
Detailed Description
Primary Objective:
Use both listed and relatively safe drug, Silymarin, to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
Patient Selection and Enrollment:
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.
Plan of the Study:
Study Design This is an open-label, randomized, comparative, double arm, single center study to assess efficacy of Silymarin as adjuvant therapy on metastatic colorectal cancer patients undergoing FOLFIRI chemotherapy in Taiwan.
Subject Number Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.
Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB) Duration of study: From the date of the IRB was approved till the 70th patient was collected.
Duration of Enrollment: From the date of the IRB was approved till the 70th patient was collected.
Duration of treatment: From the 1st patient starting chemotherapy till the 70th patient finishing the 6th cycle chemotherapy.
Duration of follow-up: From the 1st patient starting chemotherapy till 3 months after the 70th patient finishing the 6th cycle chemotherapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
CPT-11(irinotecan), silymarin, GI toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prescription of silymarin
Arm Type
Experimental
Arm Description
During six cycles of FOLFIRI chemotherapy, the patients will take silymarin (150mg) three times daily from day 1 to day 7 during one cycle of treatment.
Arm Title
control
Arm Type
No Intervention
Arm Description
During six cycles of FOLFIRI chemotherapy, the patients will not take silymarin during chemotherapy
Intervention Type
Drug
Intervention Name(s)
Silymarin
Intervention Description
During six cycles of FOLFIRI chemotherapy, the patients will take silymarin (150mg) three times daily from day 1 to day 7 during one cycle of treatment.
Primary Outcome Measure Information:
Title
GI associated adverse events
Description
Response rate and grades of GI associated adverse events (AEs) according to the Response Evaluation Criteria in Solid Tumors (version 1.1)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient who is between 20 to 80 years old
The patient who is diagnosed metastatic colorectal cancer and received chemotherapy with FOLFIRI regimen
The female patient should not be pregnant or breast-feeding
The patient who has no severe co-morbidity, such as cardiovascular, cerebrovascular, malignant hypertension, renal and hepatobiliary disease.
The patient who has no associated drug allergy to this trial.
The patient who is in compliance with prescribed medication.
The patient who is willing to sign the permit of the clinical trial.
Exclusion Criteria:
The patients who do not meet the main inclusion criteria or are not willing to sign the permit.
The patient who has viral hepatitis or carrier with impaired liver function.
Facility Information:
Facility Name
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
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