Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue: A randomized, double-blind trial, N07C2

Debra L. Barton, Heshan Liu, Shaker R. Dakhil, Breanna Linquist, Jeff A Sloan, Craig R. Nichols, Travis W. McGinn, Philip J. Stella, Grant R. Seeger, Amit Sood, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

132 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1230-1238
Number of pages9
JournalJournal of the National Cancer Institute
Volume105
Issue number16
DOIs
StatePublished - Aug 21 2013

Fingerprint

Panax
Fatigue
Neoplasms
Placebos
Terminology
Self Report
Equipment and Supplies
National Cancer Institute (U.S.)
Survivors
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue : A randomized, double-blind trial, N07C2. / Barton, Debra L.; Liu, Heshan; Dakhil, Shaker R.; Linquist, Breanna; Sloan, Jeff A; Nichols, Craig R.; McGinn, Travis W.; Stella, Philip J.; Seeger, Grant R.; Sood, Amit; Loprinzi, Charles Lawrence.

In: Journal of the National Cancer Institute, Vol. 105, No. 16, 21.08.2013, p. 1230-1238.

Research output: Contribution to journalArticle

Barton, DL, Liu, H, Dakhil, SR, Linquist, B, Sloan, JA, Nichols, CR, McGinn, TW, Stella, PJ, Seeger, GR, Sood, A & Loprinzi, CL 2013, 'Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue: A randomized, double-blind trial, N07C2', Journal of the National Cancer Institute, vol. 105, no. 16, pp. 1230-1238. https://doi.org/10.1093/jnci/djt181
Barton, Debra L. ; Liu, Heshan ; Dakhil, Shaker R. ; Linquist, Breanna ; Sloan, Jeff A ; Nichols, Craig R. ; McGinn, Travis W. ; Stella, Philip J. ; Seeger, Grant R. ; Sood, Amit ; Loprinzi, Charles Lawrence. / Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue : A randomized, double-blind trial, N07C2. In: Journal of the National Cancer Institute. 2013 ; Vol. 105, No. 16. pp. 1230-1238.
@article{bfc4f27335094c9ab0b5c3c6c170ad66,
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.",
author = "Barton, {Debra L.} and Heshan Liu and Dakhil, {Shaker R.} and Breanna Linquist and Sloan, {Jeff A} and Nichols, {Craig R.} and McGinn, {Travis W.} and Stella, {Philip J.} and Seeger, {Grant R.} and Amit Sood and Loprinzi, {Charles Lawrence}",
year = "2013",
month = "8",
day = "21",
doi = "10.1093/jnci/djt181",
language = "English (US)",
volume = "105",
pages = "1230--1238",
journal = "Journal of the National Cancer Institute",
issn = "0027-8874",
publisher = "Oxford University Press",
number = "16",

}

TY - JOUR

T1 - Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue

T2 - A randomized, double-blind trial, N07C2

AU - Barton, Debra L.

AU - Liu, Heshan

AU - Dakhil, Shaker R.

AU - Linquist, Breanna

AU - Sloan, Jeff A

AU - Nichols, Craig R.

AU - McGinn, Travis W.

AU - Stella, Philip J.

AU - Seeger, Grant R.

AU - Sood, Amit

AU - Loprinzi, Charles Lawrence

PY - 2013/8/21

Y1 - 2013/8/21

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84883177002&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84883177002&partnerID=8YFLogxK

U2 - 10.1093/jnci/djt181

DO - 10.1093/jnci/djt181

M3 - Article

C2 - 23853057

AN - SCOPUS:84883177002

VL - 105

SP - 1230

EP - 1238

JO - Journal of the National Cancer Institute

JF - Journal of the National Cancer Institute

SN - 0027-8874

IS - 16

ER -