A Double-Blind, Randomized, Placebo-Controlled Trial ofPanax Ginsengfor Cancer-Related Fatigue in Patients With Advanced Cancer

Abstract

Despite the high frequency, severity, and effects of cancer-related fatigue (CRF) on the quality of life (QoL) of patients with cancer, limited treatment options are available. The primary objective of this study was to compare the effects of oral extract (PG) and placebo on CRF. Secondary objectives were to determine the effects of PG on QoL, mood, and function. In this randomized, double-blind, placebo-controlled study, patients with CRF ≥4/10 on the Edmonton Symptom Assessment System (ESAS) were eligible. Based on a pilot study, we randomized patients to receive either 400 mg of standardized PG twice daily or a matching placebo for 28 days. The primary end point was change in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale from baseline to day 29. Of 127 patients, 112 (88.2%) were evaluable. The mean (SD) FACIT-F subscale scores at baseline, day 15, and day 29 were 22.4 (10.1), 29.9 (10.6), and 30.1 (11.6) for PG (<.001), and 24.0 (9.4), 30.0 (10.1), and 30.4 (11.5) for placebo (<.001). Mean (SD) improvement in the FACIT-F subscale at day 29 was not significantly different in the PG than in the placebo group (7.5 [12.7] vs 6.5 [9.9]; =.67). QoL, anxiety, depression, symptoms, and functional scores were not significantly different between the PG and placebo groups. Improvement in the FACIT-F subscale correlated with baseline scores (=.0005), Hospital Anxiety and Depression Scale results (=.032), and sex (=.023). There were fewer any-grade toxicities in the PG versus placebo group (28/63 vs 33/64; =.024). Both PG and placebo result in significant improvement in CRF. PG was not significantly superior to placebo after 4 weeks of treatment. There is no justification to recommend the use of PG for CRF. Further studies are needed. ClinicalTrials.gov identifier: NCT01375114.

Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression

“…In 11 trials, some of the data needed for meta-analysis were not published in the trial paper; therefore, we sought contact with authors. We retrieved the necessary information from four of the 11 studies, making the number of trials available for quantitative analysis 2322–29 31–34 39 41–47 49–51 (online supplementary material for details on rejected articles).…”

Isoquercetin as an Adjunct Therapy in Patients With Kidney Cancer Receiving First-Line Sunitinib (QUASAR): Results of a Phase I Trial

“…As reported by the NCCN guidelines, only a few pharmacological psychostimulant agents are included as potential effective interventions to relieve cancer-related fatigue. Although the use of nutritional supplements appears attractive for multiple reasons (e.g., because of their safety and patient compliance), none of those investigated in randomized controlled trials, including coenzyme Q10, American ginseng and acetylcarnitine, have proven to be more effective than placebo (Cruciani et al, 2012 ; Lesser et al, 2013 ; Yennurajalingam et al, 2017 )- also because of a clinically significant placebo effect.…”

Clinical and Preclinical Systematic Review of Panax ginseng C. A. Mey and Its Compounds for Fatigue

“…Panax ginseng C.A. Mey is believed to improve overall quality of life (QoL), including energy and vitality, particularly during times of fatigue or stress (Yennurajalingam et al, 2017).…”