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

Korea Ginseng

Status: Completed

Conditions: Colorectal Cancer

Treatments: Dietary Supplement: Korean Red Ginseng; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02039635

KGC-S-02

Details and patient eligibility

About

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)

Enrollment: 438 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

438 participants in 2 patient groups, including a placebo group

Korean Red Ginseng

Experimental group

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

Treatment:

Dietary Supplement: Korean Red Ginseng

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo