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Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer (KRG)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korean Red Ginseng
Placebo
Sponsored by
Korea Ginseng Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring cancer, cancer related fatigue, Korean red ginseng, chemotherapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Korea Ginseng Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Korean Red Ginseng

Placebo

Arm Description

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

Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo

Outcomes

Primary Outcome Measures

Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks

Secondary Outcome Measures

Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake of trial drugs 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
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score after 8 and 16 weeks of trial drug in take
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
Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake
Change in blood cortisol level after 16 weeks of trial drug intake
Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake
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

Full Information

First Posted
December 16, 2013
Last Updated
August 9, 2017
Sponsor
Korea Ginseng Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02039635
Brief Title
Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer
Acronym
KRG
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Ginseng Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
cancer, cancer related fatigue, Korean red ginseng, chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Korean Red Ginseng
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Korean Red Ginseng
Intervention Description
Given Orally
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Given Orally
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake
Time Frame
Baseline, 16 weeks
Title
Change in blood cortisol level after 16 weeks of trial drug intake
Time Frame
Baseline, 16 weeks
Title
Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake
Time Frame
Baseline, 16 weeks
Title
adverse events
Description
Voluntary reports of adverse events and collected reports of adverse events (agitation, anxiety, headache, insomnia, vomiting) Laboratory and physical test ECOG performance ECG
Time Frame
Baseline, 8 and 16 weeks
Other Pre-specified Outcome Measures:
Title
Tumor response after 8 and 16 weeks of trial drug intake
Time Frame
Baseline, 8 and 16 weeks
Title
Progressive-free survival (PFS)
Time Frame
up to 16 weeks
Title
Change in blood cytokine(IL-2, IL-8, IL-10) level after 16 weeks of trial drug intake
Time Frame
Baseline, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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) Exclusion Criteria: 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
Facility Information:
Facility Name
Korea Ginseng Corporation
City
Shinseongdong
State/Province
Daejeon
ZIP/Postal Code
305-805
Country
Korea, Republic of

12. IPD Sharing Statement

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Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer

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