Korean red ginseng for cancer-related fatigue in colorectal cancer patients with chemotherapy: A randomised phase III trial.

2020-05
European journal of cancer (Oxford, England : 1990) 130
- Jin Won Kim
- Sae Won Han
- Jae Yong Cho
- Ik-Joo Chung
- Jong Gwang Kim
- Kyung Hee Lee
- Keon Uk Park
- Sun Kyung Baek
- Sang Cheul Oh
- Myung Ah Lee
- Doyeun Oh
- Byoungyong Shim
- Joong Bae Ahn
- Dongbok Shin
- Jae Won Lee
- Yeul Hong Kim

PubMed: 32172198
DOI: 10.1016/j.ejca.2020.02.018

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 219
Population: colorectal cancer patients who received mFOLFOX-6
Methods: randomised and double-blinded trial, randomly assigned to either KRG 2000 mg/day (n = 219) or placebo (n = 219) for 16 weeks
Blinding: Double-blind
Duration: 16 weeks

Large Human Trial

Background

Cancer-related fatigue (CRF) is a common symptom and has a negative impact on prognosis in cancer patients. CRF could be improved by Korean red ginseng (KRG).

Patients and methods

For this randomised and double-blinded trial, colorectal cancer patients who received mFOLFOX-6 were randomly assigned to either KRG 2000 mg/day (n = 219) or placebo (n = 219) for 16 weeks. CRF was evaluated using the mean area under the curve (AUC) change from baseline of brief fatigue inventory (BFI) as the primary endpoint. Fatigue-related quality of life, stress, and adverse events were evaluated as secondary endpoints.

Results

In the full analysis group, KRG up to 16 weeks improved CRF by the mean AUC change from baseline of BFI compared to placebo, particularly in "Mood" and "Walking ability" (P = 0.038, P = 0.023, respectively). In the per-protocol group, KRG led to improved CRF in the global BFI score compared with the placebo (P = 0.019). Specifically, there were improvements in "Fatigue right now," "Mood," "Relations with others," "Walking ability," and "Enjoyment of life" at 16 weeks (P = 0.045, P = 0.006, P = 0.028, P = 0.003, P = 0.036, respectively). In subgroups of female patients, ≥60 years old, with high compliance (≥80%) or more baseline fatigue, the beneficial effects of KRG were more enhanced than that of placebo. Although neutropenia was more frequent in KRG than placebo, the incidence of all adverse events was similar.

Conclusions

KRG could be safely combined with mFOLFOX-6 chemotherapy in colorectal cancer patients, and reduced CRF compared with placebo.

Research Insights

Red Ginseng→Improved Enjoyment of Life
there were improvements in ... 'Enjoyment of life' at 16 weeks (P = 0.036)
Effect
Beneficial
Effect size
Small
Dose
2000 mg/day
Red Ginseng→Improved Interpersonal Relationship
there were improvements in ... 'Relations with others' ... at 16 weeks (P = 0.028)
Effect
Beneficial
Effect size
Small
Dose
2000 mg/day
Red Ginseng→Improved Mood
In the full analysis group, KRG up to 16 weeks improved CRF by the mean AUC change from baseline of BFI compared to placebo, particularly in 'Mood' ... (P = 0.038)
Effect
Beneficial
Effect size
Small
Dose
2000 mg/day
Red Ginseng→Improved Walking Ability
In the full analysis group, KRG up to 16 weeks improved CRF by the mean AUC change from baseline of BFI compared to placebo, particularly in ... 'Walking ability' (P = 0.023)
Effect
Beneficial
Effect size
Small
Dose
2000 mg/day
Red Ginseng→Reduced Cancer-Related Fatigue
In the per-protocol group, KRG led to improved CRF in the global BFI score compared with the placebo (P = 0.019).
Effect
Beneficial
Effect size
Small
Dose
2000 mg/day
Red Ginseng→Reduced Fatigue
there were improvements in 'Fatigue right now' ... at 16 weeks (P = 0.045)
Effect
Beneficial
Effect size
Small
Dose
2000 mg/day

Adverse Events Reported

Red Ginseng→neutropenia
Although neutropenia was more frequent in KRG than placebo, the incidence of all adverse events was similar.
Finding
Increased risk
Significant
Yes
Red Ginseng→Overall tolerability
the incidence of all adverse events was similar.
Finding
No significant difference
Significant
Yes