title: Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2.
abstract: BACKGROUND
  Safe, effective interventions to improve cancer-related fatigue (CRF) are needed because it remains a prevalent, distressing, and activity-limiting symptom. Based on pilot data, a phase III trial was developed to evaluate the efficacy of American ginseng on CRF.
  
  
  METHODS
  A multisite, double-blind trial randomized fatigued cancer survivors to 2000mg of American ginseng vs a placebo for 8 weeks. The primary endpoint was the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) at 4 weeks. Changes from baseline at 4 and 8 weeks were evaluated between arms by a two-sided, two-sample t test. Toxicities were evaluated by self-report and the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) provider grading.
  
  
  RESULTS
  Three hundred sixty-four participants were enrolled from 40 institutions. Changes from baseline in the general subscale of the MFSI-SF were 14.4 (standard deviation [SD] = 27.1) in the ginseng arm vs 8.2 (SD = 24.8) in the placebo arm at 4 weeks (P = .07). A statistically significant difference was seen at 8 weeks with a change score of 20 (SD = 27) for the ginseng group and 10.3 (SD = 26.1) for the placebo group (P = .003). Greater benefit was reported in patients receiving active cancer treatment vs those who had completed treatment. Toxicities per self-report and CTCAE grading did not differ statistically significantly between arms.
  
  
  CONCLUSIONS
  Data support the benefit of American ginseng, 2000mg daily, on CRF over an 8-week period. There were no discernible toxicities associated with the treatment. Studies to increase knowledge to guide the role of ginseng to improve CRF are needed.
authors.affiliation: Alliance Statistics and Data Center, Mayo Clinic Rochester, Rochester, MN 55905, USA. barton.debra@mayo.edu
authors.forename: Debra L
authors.initials: DL
authors.lastname: Barton
authors.forename: Heshan
authors.initials: H
authors.lastname: Liu
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Dakhil
authors.forename: Breanna
authors.initials: B
authors.lastname: Linquist
authors.forename: Jeff A
authors.initials: JA
authors.lastname: Sloan
authors.forename: Craig R
authors.initials: CR
authors.lastname: Nichols
authors.forename: Travis W
authors.initials: TW
authors.lastname: McGinn
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Stella
authors.forename: Grant R
authors.initials: GR
authors.lastname: Seeger
authors.forename: Amit
authors.initials: A
authors.lastname: Sood
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D005894:Panax; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts