Colorectal CancerKRGNCT02039635
Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer
A study testing Korean Red Ginseng in people with Colorectal Cancer, run by Korea Ginseng Corporation at 1 site in South Korea.
Trial summary
Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean Red Ginseng is effective compared with a placebo in chemotherapy. The purpose of this study is to determine whether Korean Red Ginseng is effective in the treatment of the fatigue from colorectal cancer with… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Korean Red Ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 438 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Mar 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years and older
- Person who agreed to participate in this study and signed voluntarily on the written informed consent form
- Person who is confirmed as colorectal cancer through histological and image diagnosis and scheduled for adjuvant or palliative therapy with mFOLFOX-6 regimen
- Fertile patients with negative pregnancy test confirmed and who has agreed to use effective contraception
- Person who is able to fully communicate with the physician about his/her fatigue status and is able to completely fill out the questionnaires
- Life expectancy more than 6 months
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- Performance status of ECOG grade 0~1
- Hb ≥ 9g/dL
- Person with moderate liver function (AST, ALT ≤ 2.5 × ULN)
- Person with moderate renal function (Cr ≤ 1.5 × ULN)
Who cannot join
- Pregnant or nursing women
- Primary brain cancer, brain metastases or other CNS malignancy, including CNS lymphoma
- No controlled pain despite the use if analgesics.
- Person showing hypothyroidism despite the hormone treatment
- Person with insomnia despite an appropriate treatment
- No controlled hypertension (DBP >100mmHg or SBP >160mmHg)
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- Person who has experience of hypersensitivity to the trial drug (ginseng) components
- Person with autoimmune disorders (Multiple sclerosis, Lupus, rheumarthritis etc.)
- Person who is alcoholic dependent or has psychiatric disorder
- Person who has cognitive or psychiatric problems
- Person who has an experience of chemotherapy agents use 6 months before a screening visit
- Person who had a surgery 2 weeks before a screening visit
- Person who had taken herbal medicinal product (including Chinese medicine) 4 weeks before the screening visit
- Person who has medical status that is judged to affect the result or who is judged as inappropriate for the study by the physician
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea Ginseng Corporation
Shinseongdong, Daejeon, 305-805
About this study
Official title: A Study of Korean Red Ginseng for Evaluation of Improvement of Cancer-related Fatigue in Patients With Colorectal Cancer With Chemotherapy: A Randomized, Double-blind, Placebo-Controlled, Parallel, Multicenter Trial
Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean Red Ginseng is effective compared with a placebo in chemotherapy.
The purpose of this study is to determine whether Korean Red Ginseng is effective in the treatment of the fatigue from colorectal cancer with chemotherapy.(modified FOLFOX-6)
- Conditions
- Colorectal Cancer
- Being tested
- Korean Red Ginseng, Placebo
- Keywords
- cancer, cancer related fatigue, Korean red ginseng, chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red GinsengDietary supplement
Given Orally
PlaceboDietary supplement
Given Orally
| Study group | Role | What they receive |
|---|---|---|
| Korean Red Ginseng | Experimental | Patients receive oral Korean Red Ginseng twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses.
Intervention: Dietary Supplement: Korean Red Ginseng Receives: Dietary Supplement: Korean Red Ginseng |
| Placebo | Placebo comparator | Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses.
Intervention: Other: Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks
Measured: From Baseline up to 16 weeks
Secondary outcomes (8)
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake of trial drugs up to 8 weeks
Measured: From Baseline up to 8 weeks
Change in Functional Assessment of Chronic Illness Therapy-Fatigue Trial Outcome Index (FACIT-F TOI) after 8 and 16 weeks of trial drug intake
Measured: Baseline, 8 and 16 weeks
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score after 8 and 16 weeks of trial drug in take
Measured: Baseline, 8 and 16 weeks
The percentage of subjects whom the Functional Assessment of Cancer Therapy-General (FACT-G) score decreased more than 20 scores after 8 and 16 weeks of trial drug intake
Measured: Baseline, 8 and 16 weeks
Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake
Measured: Baseline, 16 weeks
Change in blood cortisol level after 16 weeks of trial drug intake
Measured: Baseline, 16 weeks
Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake
Measured: Baseline, 16 weeks
adverse events
- Voluntary reports of adverse events and collected reports of adverse events (agitation, anxiety, headache, insomnia, vomiting)
- Laboratory and physical test
- ECOG performance
- ECG
Measured: Baseline, 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Ginseng Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039635
- Sponsor's protocol ID
- KGC-S-02
- Acronym
- KRG
- Status last verified
- Jul 2017
- First submitted
- 16 Dec 2013
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Korean Red Ginseng for Evaluation of Improvement of Cancer-related Fatigue in Patients With Colorectal Cancer With Chemotherapy: A Randomized, Double-blind, Placebo-Controlled, Parallel, Multicenter Trial
- ClinicalTrials.gov ID
- NCT02039635
- Acronym / sponsor ID
- KRG / KGC-S-02
- Conditions
- Colorectal Cancer
- Keywords
- cancer, cancer related fatigue, Korean red ginseng, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Korea Ginseng CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Jan 2014 (estimated)
- 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.
Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean Red Ginseng is effective compared with a placebo in chemotherapy.
The purpose of this study is to determine whether Korean Red Ginseng is effective in the treatment of the fatigue from colorectal cancer with chemotherapy.(modified FOLFOX-6)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Korean Red Ginseng | Experimental | Dietary Supplement: Korean Red GinsengPatients receive oral Korean Red Ginseng twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Dietary Supplement: Korean Red Ginseng |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 20 years and older
- Person who agreed to participate in this study and signed voluntarily on the written informed consent form
- Person who is confirmed as colorectal cancer through histological and image diagnosis and scheduled for adjuvant or palliative therapy with mFOLFOX-6 regimen
- Fertile patients with negative pregnancy test confirmed and who has agreed to use effective contraception
- Person who is able to fully communicate with the physician about his/her fatigue status and is able to completely fill out the questionnaires
Key exclusion criteria (14 listed)
- Pregnant or nursing women
- Primary brain cancer, brain metastases or other CNS malignancy, including CNS lymphoma
- No controlled pain despite the use if analgesics.
- Person showing hypothyroidism despite the hormone treatment
- Person with insomnia despite an appropriate treatment
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 |
|---|---|---|
| Korean Red GinsengGiven Orally | Dietary supplement | Korean Red Ginseng |
| PlaceboGiven Orally | Dietary supplement | Placebo |
Primary outcome
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks
Time frame: From Baseline up to 16 weeks
8 secondary outcomes
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake of trial drugs up to 8 weeks
Time frame: From Baseline up to 8 weeks
Change in Functional Assessment of Chronic Illness Therapy-Fatigue Trial Outcome Index (FACIT-F TOI) after 8 and 16 weeks of trial drug intake
Time frame: Baseline, 8 and 16 weeks
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score after 8 and 16 weeks of trial drug in take
Time frame: Baseline, 8 and 16 weeks
The percentage of subjects whom the Functional Assessment of Cancer Therapy-General (FACT-G) score decreased more than 20 scores after 8 and 16 weeks of trial drug intake
Time frame: Baseline, 8 and 16 weeks
Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake
Time frame: Baseline, 16 weeks
Change in blood cortisol level after 16 weeks of trial drug intake
Time frame: Baseline, 16 weeks
Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake
Time frame: Baseline, 16 weeks
adverse events
Time frame: Baseline, 8 and 16 weeks
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 11 Aug 2017.
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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 study testing Korean Red Ginseng in people with Colorectal Cancer, run by Korea Ginseng Corporation at 1 site in South Korea.
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 10 inclusion and 14 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 11 Aug 2017. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks (time frame: From Baseline up to 16 weeks). 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 11 Aug 2017.