Clinical trial NCT02039635: Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer
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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: cancer
cancer related fatigue
Korean red ginseng
chemotherapy
Lead sponsor: Korea Ginseng Corporation
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 438
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)


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

Primary outcomes:
measure: Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks
timeFrame: 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
timeFrame: From Baseline up to 8 weeks
measure: Change in Functional Assessment of Chronic Illness Therapy-Fatigue Trial Outcome Index (FACIT-F TOI) after 8 and 16 weeks of trial drug intake
timeFrame: Baseline, 8 and 16 weeks
measure: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score after 8 and 16 weeks of trial drug in take
timeFrame: Baseline, 8 and 16 weeks
measure: 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
timeFrame: Baseline, 8 and 16 weeks
measure: Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake
timeFrame: Baseline, 16 weeks
measure: Change in blood cortisol level after 16 weeks of trial drug intake
timeFrame: Baseline, 16 weeks
measure: Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake
timeFrame: Baseline, 16 weeks
measure: adverse events
timeFrame: Baseline, 8 and 16 weeks
Other outcomes:
measure: Tumor response after 8 and 16 weeks of trial drug intake
timeFrame: Baseline, 8 and 16 weeks
measure: Progressive-free survival (PFS)
timeFrame: up to 16 weeks
measure: Change in blood cytokine(IL-2, IL-8, IL-10) level after 16 weeks of trial drug intake
timeFrame: Baseline, 16 weeks
Locations:
city: Shinseongdong
country: Korea, Republic of
facility: Korea Ginseng Corporation
state: Daejeon
Study officials:
References: