Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: A randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA

Debra L. Barton, Gamini S. Soori, Brent A Bauer, Jeff A Sloan, Patricia A. Johnson, Cesar Figueras, Steven Duane, Bassam Mattar, Heshan Liu, Pamela J. Atherton, Bradley Christensen, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

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Abstract

Purpose 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 Methods 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. Results 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. Conclusion 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.

Original languageEnglish (US)
Pages (from-to)179-187
Number of pages9
JournalSupportive Care in Cancer
Volume18
Issue number2
DOIs
StatePublished - Feb 2010

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Panax
Fatigue
Placebos
Neoplasms
Equipment and Supplies
Area Under Curve
Outcome Assessment (Health Care)

Keywords

  • American ginseng
  • Botanicals
  • Cancer-related fatigue
  • Panax quinquefolius

ASJC Scopus subject areas

  • Oncology
  • Medicine(all)

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Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue : A randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. / Barton, Debra L.; Soori, Gamini S.; Bauer, Brent A; Sloan, Jeff A; Johnson, Patricia A.; Figueras, Cesar; Duane, Steven; Mattar, Bassam; Liu, Heshan; Atherton, Pamela J.; Christensen, Bradley; Loprinzi, Charles Lawrence.

In: Supportive Care in Cancer, Vol. 18, No. 2, 02.2010, p. 179-187.

Research output: Contribution to journalArticle

Barton, Debra L. ; Soori, Gamini S. ; Bauer, Brent A ; Sloan, Jeff A ; Johnson, Patricia A. ; Figueras, Cesar ; Duane, Steven ; Mattar, Bassam ; Liu, Heshan ; Atherton, Pamela J. ; Christensen, Bradley ; Loprinzi, Charles Lawrence. / Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue : A randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. In: Supportive Care in Cancer. 2010 ; Vol. 18, No. 2. pp. 179-187.
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abstract = "Purpose 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 Methods 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. Results 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. Conclusion 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.",
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T1 - Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue

T2 - A randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA

AU - Barton, Debra L.

AU - Soori, Gamini S.

AU - Bauer, Brent A

AU - Sloan, Jeff A

AU - Johnson, Patricia A.

AU - Figueras, Cesar

AU - Duane, Steven

AU - Mattar, Bassam

AU - Liu, Heshan

AU - Atherton, Pamela J.

AU - Christensen, Bradley

AU - Loprinzi, Charles Lawrence

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Y1 - 2010/2

N2 - Purpose 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 Methods 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. Results 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. Conclusion 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.

AB - Purpose 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 Methods 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. Results 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. Conclusion 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.

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