Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer
KRG
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
1 other identifier
interventional
438
1 country
1
Brief 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 chemotherapy.(modified FOLFOX-6)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Dec 2013
Typical duration for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedAugust 11, 2017
July 1, 2017
2.7 years
December 16, 2013
August 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks
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
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
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
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
Baseline, 8 and 16 weeks
Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake
Baseline, 16 weeks
- +3 more secondary outcomes
Other Outcomes (3)
Tumor response after 8 and 16 weeks of trial drug intake
Baseline, 8 and 16 weeks
Progressive-free survival (PFS)
up to 16 weeks
Change in blood cytokine(IL-2, IL-8, IL-10) level after 16 weeks of trial drug intake
Baseline, 16 weeks
Study Arms (2)
Korean Red Ginseng
EXPERIMENTALPatients 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 COMPARATORPatients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea Ginseng Corporation
Shinseongdong, Daejeon, 305-805, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2013
First Posted
January 17, 2014
Study Start
December 1, 2013
Primary Completion
August 1, 2016
Study Completion
March 1, 2017
Last Updated
August 11, 2017
Record last verified: 2017-07