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

Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039635
• Other study ID #: KGC-S-02
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: August 9, 2017
• Start date: December 2013
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: Korea Ginseng Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 chemotherapy.(modified FOLFOX-6)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: March 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Fatigue

Intervention

Dietary Supplement:
• Korean Red Ginseng
Given Orally
• Placebo
Given Orally

Locations

Country	Name	City	State
Korea, Republic of	Korea Ginseng Corporation	Shinseongdong	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Korea Ginseng Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tumor response after 8 and 16 weeks of trial drug intake		Baseline, 8 and 16 weeks
Other	Progressive-free survival (PFS)		up to 16 weeks
Other	Change in blood cytokine(IL-2, IL-8, IL-10) level after 16 weeks of trial drug intake		Baseline, 16 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake		Baseline, 16 weeks
Secondary	Change in blood cortisol level after 16 weeks of trial drug intake		Baseline, 16 weeks
Secondary	Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake		Baseline, 16 weeks
Secondary	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