Metastatic Colorectal CancerPhase 4NCT03130634
The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
A Phase 4 study testing Silymarin in people with Metastatic Colorectal Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Silymarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2016to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, 807
About this study
Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
Read the 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
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Silymarin
- Keywords
- CPT-11(irinotecan), silymarin, GI toxicity
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilymarinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Silymarin |
| control | No intervention | During six cycles of FOLFIRI chemotherapy, the patients will not take silymarin during chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startApr 2016
- Primary completionJun 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130634
- Sponsor's protocol ID
- KMUHIRB-F(II)-20160038
- Status last verified
- May 2020
- First submitted
- 22 Apr 2017
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
- ClinicalTrials.gov ID
- NCT03130634
- Acronym / sponsor ID
- KMUHIRB-F(II)-20160038
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- CPT-11(irinotecan), silymarin, GI toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prescription of silymarin | Experimental | Drug: SilymarinDuring 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. |
| control | No intervention | –During six cycles of FOLFIRI chemotherapy, the patients will not take silymarin during chemotherapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilymarinDuring 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 | prescription of silymarin |
Primary outcome
GI associated adverse events
Time frame: 3 months
Response rate and grades of GI associated adverse events (AEs) according to the Response Evaluation Criteria in Solid Tumors (version 1.1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silymarin in people with Metastatic Colorectal Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI associated adverse events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.