The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment

Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Silymarin

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient who is between 20 to 80 years old
2. The patient who is diagnosed metastatic colorectal cancer and received chemotherapy with FOLFIRI regimen
3. The female patient should not be pregnant or breast-feeding
4. The patient who has no severe co-morbidity, such as cardiovascular, cerebrovascular, malignant hypertension, renal and hepatobiliary disease.
5. The patient who has no associated drug allergy to this trial.
6. The patient who is in compliance with prescribed medication.
7. The patient who is willing to sign the permit of the clinical trial.

Exclusion Criteria:

1. The patients who do not meet the main inclusion criteria or are not willing to sign the permit.
2. The patient who has viral hepatitis or carrier with impaired liver function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prescription of silymarin; 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.	Drug: Silymarin; 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.
No Intervention: control; During six cycles of FOLFIRI chemotherapy, the patients will not take silymarin during chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: April 22, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: silymarin; CPT-11(irinotecan); GI toxicity
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Silymarin
• Other Study ID Numbers: KMUHIRB-F(II)-20160038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No