A pilot, multi-dose, placebo-controlled evaluation of american ginseng (panax quinquefolius) to improve cancer-related fatigue: NCCTG trial N03CA.

Reviewer: Christine Hill, MD
Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 3 de junio del 2007

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Presenter: Soori, G.S.
Presenter's Affiliation: Mayo Clinic College of Medicine, Rochester, MN.
Type of Session: Scientific

Background

  • Fatigue is an extremely important issue for cancer patients, recently having been reported to occur in 58% of patients undergoing cancer treatment, as compared to pain, encountered by 22%, and nausea and vomiting, reported by 18% (Am Oncol, 2000).
  • Although fatigue in cancer patients has been studied in prior randomized controlled trials, no benefit from pharmacologic treatment has been demonstrated thus far.
  • Ginseng is a commonly utilized herbal medication, felt to restore energy and emotional balance. Animal data suggests that it may have anti-fatigue efficacy.
  • This study was carried out to evaluate the effects of American (Wisconsin) Ginseng versus placebo for cancer-related fatigue.

Materials and Methods

  • This study was designed as a double-blinded, placebo-controlled, randomized trial.
  • Eligible patients reported fatigue of at least 4 on a 1-10 scale, present for at least 1 month. Exclusionary criteria included life expectancy < 6 months, prior use of ginseng, chronic systemic steroid use, brain malignancy, and the presence of other fatigue-inducing etiology (i.e. pain).
  • Patients were randomized to one of four arms: placebo, 750 mg/d American Ginseng, 1000 mg/d American Ginseng or 2000 mg/d American Ginseng, with twice-daily dosing in all arms.
  • Improvement in the area under the curve (AUC) for activity interference of the Brief Fatigue Inventory (BFI) was the primary endpoint of the study. Several other survey-based assessments were carried out to evaluate vitality, physical well-being, and treatment satisfaction. Surveys included both specific and open-ended questions with regards to symptom improvement and change.
  • Endpoints were measured at baseline, 4 weeks, and 8 weeks.

Results

  • A total of 282 patients were enrolled and randomized over a 9 month period of time, and 176 were analyzed at 8 weeks. Approximately 50% of patients were receiving chemotherapy at the time of enrollment. The remaining patients had completed cancer-related treatments, with 8% complaining of chronic, long-term fatigue lasting for greater than 6 months after the completion of treatment.
  • The primary endpoint, AUC for activity interference, did not change significantly with treatment with American Ginseng, but did show a trend towards improvement with increasing dose of American Ginseng (At eight weeks: 460 for placebo, 467 for 750 mg/d American Ginseng, 480 for 1000 mg/d, 551 for 2000 mg/d, p = 0.08). The authors note that higher values correspond with greater improvement.
  • Patients randomized to higher American Ginseng doses (1000 mg/d or 2000 mg/d) reported an increased mean change from baseline with regards to vitality (7.3 for placebo, 7.8 for 750 mg/d American Ginseng, 14.6 for 1000 mg/d, 10.5 for 2000 mg/d).
  • Patients randomized to 1000 mg/d American Ginseng reported a mean change in overall physical well-being of 12, versus 5.6 for the placebo group, 5.3 for 750 mg/d American ginseng, and 6.5 for 2000 mg/d.
  • Moderate to very much better fatigue levels with study drug were reported by 25% and 27% of patients randomized to higher doses of American Ginseng (1000 mg/d and 2000 mg/d, respectively), as compared to 10% of patients randomized to either placebo or American Ginseng 750 mg/d.
  • Satisfaction with treatment was reported by 13% of patients randomized to placebo, 24% of patients randomized to American Ginseng 750 mg/d, 33% of patients randomized to American Ginseng 1000 mg/d, and 34% of patients randomized to American Ginseng 2000 mg/d.
  • Grades I-II toxicities, namely nausea and insomnia, were reported equally across the four arms.

Author's Conclusions

  • The authors conclude that American Ginseng doses of 1000 - 2000 mg/d may be effective for reducing cancer-related fatigue.
  • Treatment-related satisfaction appears to be increased with higher doses as compared to placebo or lower doses.
  • Patients taking higher doses of American ginseng were over twice as likely to report both improvements in fatigue levels and satisfaction with treatment as those randomized to placebo or lower dose American Ginseng.
  • American Ginseng is well-tolerated, with no increased toxicity reported over placebo.

Clinical/Scientific Implications

  • Although no significant difference was observed between the four arms of this study with regards to its primary endpoint, AUC for activity interference, trends within the study seem to indicate improvements in fatigue, overall well-being, and treatment satisfaction with increasing doses of American Ginseng.
  • Of note, patients randomized to placebo reported improvements in vitality, fatigue level, general well-being, and treatment satisfaction at similar levels to those randomized to take American ginseng, 750 mg/day. This represents a substantial placebo effect.
  • Given the low side-effect profile associated with American Ginseng, as well as its potential demonstrated in this study to reduce cancer-related fatigue, further study of its efficacy seems warranted; however, the placebo effect noted above, as well as the lack of statistically significant improvement in the primary endpoint of this study, should be considered in the setting of clinical patient care.


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