Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments korean red ginseng, placebo
Sponsor Korea Ginseng Corporation
Start date December 2013
End date September 2016
Trial size 438 participants
Trial identifier NCT02039635, KGC-S-02

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(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
korean red ginseng
Given Orally
(Placebo Comparator)
Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo
placebo
Given Orally

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Korea Ginseng Corporation.