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

NCT03130634 | Completed Phase 4 DMC

• 1 other identifier: KMUHIRB-F(II)-20160038
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

CPT-11(irinotecan); silymarin; GI toxicity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

prescription of silymarin

EXPERIMENTAL

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

control

NO INTERVENTION

During six cycles of FOLFIRI chemotherapy, the patients will not take silymarin during chemotherapy

Interventions

Silymarin DRUG

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.

prescription of silymarin

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient who has viral hepatitis or carrier with impaired liver function.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2017
• First Posted: April 26, 2017
• Study Start: April 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

TW (1)