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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Korean Red Ginseng; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 438
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon
    • Shinseongdong, Daejeon, Korea, Republic of, 305-805
      • Korea Ginseng Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Korean Red Ginseng; 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	Dietary supplement: Korean Red Ginseng; Given Orally
Placebo Comparator: Placebo; Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo	Dietary supplement: Placebo; Given Orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in blood cortisol level after 16 weeks of trial drug intake		Baseline, 16 weeks
Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake		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	Baseline, 8 and 16 weeks

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Korea Ginseng Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: chemotherapy; cancer; cancer related fatigue; Korean red ginseng
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Fatigue; Colorectal Neoplasms
• Other Study ID Numbers: KGC-S-02