Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA
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This pilot trial sought to investigate whether any of three doses of American ginseng (Panax quinquefolius) might help cancer-related fatigue. A secondary aim was to evaluate toxicity.
Eligible adults with cancer were randomized in a double-blind manner, to receive American ginseng in doses of 750, 1,000, or 2,000 mg/day or placebo given in twice daily dosing over 8 weeks. Outcome measures included the Brief Fatigue Inventory, vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36), and the Global Impression of Benefit Scale at 4 and 8 weeks.
Two hundred ninety patients were accrued to this trial. Nonsignificant trends for all outcomes were seen in favor of the 1,000- and 2,000-mg/day doses of American ginseng. Area under the curve analysis of activity interference from the Brief Fatigue Inventory was 460–467 in the placebo group and 750 mg/day group versus 480–551 in the 1,000- and 2,000-mg/day arms, respectively. Change from baseline in the vitality subscale of the SF-36 was 7.3–7.8 in the placebo and the 750-mg/day arm, versus 10.5–14.6 in the 1,000- and 2,000-mg/day arms. Over twice as many patients on ginseng perceived a benefit and were satisfied with treatment over those on placebo. There were no significant differences in any measured toxicities between any of the arms.
There appears to be some activity and tolerable toxicity at 1,000–2,000 mg/day doses of American ginseng with regard to cancer-related fatigue. Thus, further study of American ginseng is warranted.
KeywordsPanax quinquefolius American ginseng Cancer-related fatigue Botanicals
- 1.NCCN Cancer Related Fatigue Clinical Practice Guidelines in Oncology V.1.2003. http://www.nccn.org/
- 2.Mock V (2001) Fatigue management, evidence and guidelines for practice. Cancer 92(6):1699–1707. doi: 10.1002/1097-0142(20010915) 92:6+<1699::AID-CNCR1500>3.0.CO;2-9 CrossRefPubMedGoogle Scholar
- 3.Fulton C, Knowles G (2000) Cancer fatigue. Eur J Cancer Care (Engl) 9(3):167–171Google Scholar
- 4.Gutstein HB (2001) The biological basis of fatigue. Cancer 92(6):1678–1683. doi: 10.1002/1097-0142(20010915) 92:6+<1678::AID-CNCR1496>3.0.CO;2-R CrossRefPubMedGoogle Scholar
- 12.Mock V, Pickett M, Ropka M, Lin E, Grimm P, Rhodes V, McDaniel R, Grimm PM, Krumm S, McCorkle R (2001) Fatigue, physical functioning, emotional distress, and quality of life outcomes of a walking intervention during breast cancer treatment. Cancer Pract 9:119–127. doi: 10.1046/j.1523-5394.2001.009003119.x CrossRefPubMedGoogle Scholar
- 16.Burks TF (2001) New agents for the treatment of cancer-related fatigue. Cancer 92(Suppl 6):1714–1718. doi: 10.1002/1097-0142(20010915)92:6+<1714::AID-CNCR1502>3.0.CO;2-N CrossRefPubMedGoogle Scholar
- 22.Ginseng (American ginseng, Asian ginseng, Chinese ginseng, Korean red ginseng, Panax ginseng: Panax spp. Including P. ginseng C.C. Meyer and P. quinquefolius L., excluding Eleutherococcus senticosus). http://natuaralstandard.com/monographys/herssupplements/ginseng.asp. Accessed on 4 April 2007
- 26.Marasco CA, Ruiz VR, Villagomex SA, Infante BC (1996) Double-blind study of a multivitamin complex supplemented with ginseng extract. Drugs Exp Clin Res XXII 6:323–329Google Scholar
- 27.Younus J, Collins A, Wang X, Saunders M, Manuel J, Freake C, Defen P (2003) A double blind placebo controlled pilot study to evaluate the effect of ginseng on fatigue and quality of life in adult chemo-naïve cancer patients. J Clin Oncol 22:733, abstract # 2947Google Scholar
- 30.Xie JT, Maleckar SA, Yuan CS (2003) Is ginseng free from adverse effects? In: Yuan CS, Bieber E (eds) Complementary and alternative medicine, chapter 17. CRC, Boca RatonGoogle Scholar
- 32.Vuksan V, Sievenpiper JL, Koo VY, Francis T, Beljan-Zdravkovic U, Xu Z, Vidgen E (2000) American ginseng (Panax quinquefolius L) reduces postprandial glycemia in nondiabetic subjects and subjects with type 2 diabetes mellitus. Arch Intern Med 160(7):1009–1013. doi: 10.1001/archinte.160.7.1009 CrossRefPubMedGoogle Scholar
- 36.Duda RB, Zhong Y, Navas V, Li MZ, Toy BR, Alavarez JG (1999) American ginseng and breast cancer therapeutic agents synergistically inhibit MCF-7 breast cancer cell growth. J Surg Oncol 72(4):230–239. doi: 10.1002/(SICI) 1096-9098(199912) 72:4<230::AID-JSO9>3.0.CO;2-2 CrossRefPubMedGoogle Scholar
- 38.Ginseng Board of Wisconsin. http://www.ginsengboard.com. Last accessed November 2007
- 39.Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL (1999) The rapid assessment of fatigue severity in cancer patient’s use of the Brief Fatigue Inventory. Cancer 85:1186–1196. doi: 10.1002/(SICI) 1097-0142(19990301) 85:5<1186::AID-CNCR24>3.0.CO;2-N CrossRefPubMedGoogle Scholar
- 44.Sloan A, O’Fallon JR, Suman VJ (1998) Incorporating quality of life measurement into oncology clinical trials. Proc Am Stat Assoc, pp 282–287Google Scholar
- 47.Cohen J (1988) Statistical power analysis for the behavioral sciences. Erlbaum, Hillsdale, NJGoogle Scholar
- 49.Sievenpiper JL, Arnason JT, Leiter LA, Vuksan V (2003) Variable effects of American ginseng: a batch of American ginseng (Panax quinquefolius L.) with a depressed ginsenoside profile does not affect postprandial glycemia. Eur J Clin Nutr 57(2):243–248. doi: 10.1038/sj.ejcn.1601550 CrossRefPubMedGoogle Scholar