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

Supportive Care in Cancer

Volumn 18, Issue 2, 2010, Pages 179-187

  Barton, Debra L ^a   Soori, Gamini S ^b   Bauer, Brent A ^a   Sloan, Jeff A ^a   Johnson, Patricia A ^c   Figueras, Cesar ^d   Duane, Steven ^e   Mattar, Bassam ^f   Liu, Heshan ^a   Atherton, Pamela J ^a   Christensen, Bradley ^a   Loprinzi, Charles L ^a  

^a MAYO CLINIC   (United States)

^b MISSOURI VALLEY CANCER CONSORTIUM   (United States)

^c Carle Cancer Center CCOP   (United States)

^d Michigan Cancer Research Consortium   (United States)

^e Metro Minnesota Community Clinical Oncology Program   (United States)

^f WICHITA COMMUNITY CLINICAL ONCOLOGY PROGRAM   (United States)

Author keywords

American ginseng; Botanicals; Cancer related fatigue; Panax quinquefolius

Indexed keywords

HERBACEOUS AGENT; PLACEBO; PANAX QUINQUEFOLIUM SAPONIN; SAPONIN;

ADULT; AGED; AGITATION; ANXIETY; AREA UNDER THE CURVE; ARTICLE; CANCER FATIGUE; CANCER PATIENT; CANCER STAGING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DISEASE DURATION; DISEASE SEVERITY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GINSENG; GLOBAL IMPRESSION OF BENEFIT SCALE; HEADACHE; HUMAN; INSOMNIA; LIFE EXPECTANCY; MAJOR CLINICAL STUDY; MALE; NAUSEA; NERVOUSNESS; OUTCOME ASSESSMENT; PANAX QUINQUEFOLIUS; PATIENT SATISFACTION; PHASE 3 CLINICAL TRIAL; PLANT ROOT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SHORT FORM 36; SIDE EFFECT; SLEEP DISORDER; TREATMENT INDICATION; TREATMENT OUTCOME; VOMITING; FATIGUE; MIDDLE AGED; NEOPLASM; PATHOLOGY; PHYTOTHERAPY; PILOT STUDY;

DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FATIGUE; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM STAGING; NEOPLASMS; PATIENT SATISFACTION; PHYTOTHERAPY; PILOT PROJECTS; SAPONINS;

EID: 76549102297     PISSN: 09414355     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00520-009-0642-2     Document Type: Article

References (51)

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.
3. Fulton C, Knowles G (2000) Cancer fatigue. Eur J Cancer Care (Engl) 9(3):167-171.
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.
5. Berger AM, Farr LA, Kuhn BR, Fischer P, Agrawal S (2007) Values of sleep/wake, activity/rest, circadian rhythms, and fatigue prior to adjuvant breast cancer chemotherapy. J Pain Symptom Manage 33(4):398-409. doi:10.1016/j.jpainsymman.2006.09.022.
6. Lawrence DP, Kupelnick B, Miller K, Devine D, Lau J (2004) Evidence report on the occurrence, assessment, and treatment of fatigue in cancer patients. J Natl Cancer Inst Monogr 32:40-50. doi:10.1093/jncimonographs/lgh027.
7. Bower JE, Ganz PA, Desmond KA, Rowland KA, Meyerowitz JH, Belin BE, Thomas R (2000) Fatigue in breast cancer survivors: occurrences, correlates, and impact on quality of life. J Clin Oncol 18:743-753.
8. Bower JE, Ganz PA, Desmond KA, Bernaards C, Rowland JH, Meyerowitz BE, Belin TR (2006) Fatigue in long-term breast carcinoma survivors. A longitudinal investigation. Cancer 106:751-758. doi:10.1002/cncr.21671.
9. Baker F, Denniston M, Smith T, West MM (2005) Adult cancer survivors: how are they faring. Cancer 104(Suppl 11):2565-2576. doi:10.1002/cncr.21488.
10. Mitchell SA, Beck SL, Edward Hood L, Moore K, Tanner ER (2007) Putting evidence into practice: evidence-based interventions of fatigue during and following cancer and its treatment. Clin J Oncol Nurs 11(1):99-113. doi:10.1188/07. CJON.99-113.
11. Mitchell SA, Berger AM (2006) Cancer-related fatigue: the evidence base for assessment and management. Cancer J 12:374-387. doi:10.1097/00130404- 200609000-00007.
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.
13. Schwartz AL, Mori M, Gao R, Nail R, King LM, Marjorie E (2001) Exercise reduces daily fatigue in women with breast cancer receiving chemotherapy. Med Sci Sports Exerc 33:718-723. doi:10.1097/00005768-200105000-00006.
14. Stone P, Richards M, Hardy J (1998) Fatigue in patients with cancer. Eur J Cancer 34(11):1670-1676. doi:10.1016/S0959-8049 (98)00167-1.
15. Portenoy RK, Itri LM (1999) Cancer-related fatigue: guidelines for evaluation and management. Oncologist 4:1-10.
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.
17. Bruera E, Driver L, Barnes EA, Willey J, Shen L, Palmer JL, Escalante C (2003) Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: a preliminary report. J Clin Oncol 21(23):4439-4443. doi:10.1200/JCO.2003.06.156.
18. Bruera E, Valero V, Driver L, Shen L, Willey J, Zhang T, Palmer JL (2006) Patient-controlled methylphenidate for cancer fatigue: a double-blind, randomized, placebo-controlled trial. J Clin Oncol 24(13):2073-2078. doi:10.1200/JCO.2005.02.8506.
19. Bruera E, Osta E, Vlaero V, Driver L, Palmer J, Pei B, Shen L, Poulter V (2007) Donepezil for cancer-related fatigue: a doubleblind, randomized, placebo-controlled study. J Clin Oncol 25 (23):3475-3481, Part I II 493s(9003).
20. Stankoff B, Waubant E, Confavreau C, Edan G, Debouverie M, Rumback L, Moreau Tl, Pelletier J, Lubetzki C, Clanet M, French Modafinil Study Group (2005) Modafinil for fatigue in MS: a randomized placebo-controlled double blind study. Neurology 64:1139-1143.
21. Attele AS, Wu JA, Yuan C (1999) Ginseng pharmacology. Biochem Pharmacol 58:1685-1693. doi:10.1016/S0006-2952(99) 00212-9.
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.
23. Cui J (1995) Identification and quantification of ginsenosides in various commercial ginseng preparations. Eur J Pharm Sci 3:77-85. doi:10.1016/0928- 0987(94)00077-D.
24. Tadano T, Nakagawasai O, Niijima F, Tan-No K, Kisara K (2000) The effects of traditional tonics on fatigue in mice differ from those of the antidepressant imipramine: a pharmacological and behavioral study. Am J Chin Med 28(1):97-104. doi:10.1142/S0192415X0000012X.
25. Banerjee U, Izquierdo JA (1982) Antistress and antifatigue properties of Panax ginseng: comparison with piracetam. Acta Physiol Lat Am 32(4):277-285.
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 6:323-329.
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 # 2947.
28. Asafu-Adjaye EB, Wong SK (2003) Determination of ginsenosides (ginseng saponins) in dry root powder from Panax ginseng, Panax quinquefolius, and selected commercial products by liquid chromatography: interlaboratory study. J AOAC Int 86(6):1112-1123.
29. Wang X, Sakuma T, Asafu-Adjaye E, Shiu GK (1999) Determination of ginsenosides in plant extracts from Panax ginseng and Panax quinquefolius L. by LC/MS/MS. Anal Chem 8:1579-1584. doi:10.1021/ac980890p.
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 Raton.
31. Wang LC, Lee TF (1998) Effect of ginseng saponins on exercise performance in non-trained rats. Planta Med 64(2):130-133. doi:10.1055/s-2006-957389.
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.
33. Sotaniemi EA, Haapakoski E, Rautio A (1995) Ginseng therapy in non-insulin-dependent diabetic patients. Diabetes Care 18 (10):1373-1375. doi:10.2337/diacare.18.10.1373.
34. King ML, Adler SR, Murphy LL (2006) Extraction-dependent effects of American ginseng (Panax quinquefolium) on human breast cancer cell proliferation and estrogen receptor activation. Integr Cancer Ther 5(3):236-243. doi:10.1177/1534735406291341.
35. King ML, Murphy LL (2007) American ginseng (Panax quinquefolius L.) extract alters mitogen-activated protein kinase cell signaling and inhibits proliferation of MCF-7 cells. J Exp Ther Oncol 6:147-155.
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.
37. Bahrke MS, Morgan WR (2000) Evaluation of the ergogenic properties of ginseng: an update. Sports Med 29(2):113-133. doi:10.2165/00007256-200029020- 00004.
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.
40. Ware JE, Sherbourne CD (1992) The MOS 36-Item Short-Form Health Survey (SF-36). Conceptual framework and item selection. Med Care 30(6):473-481. doi:10.1097/00005650-199206000-00002.
41. Buysse D, Reynolds C, Monk T, Berman S, Kupfer DJ (1989) The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 28(2):193-213. doi:10.1016/0165-1781(89)90047-4.
42. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR, Sloan JA, Clinical Significance Consensus Meeting Group (2002) Methods to explain the clinical significance of health status measures. Mayo Clin Proc 77:371-383. doi:10.4065/77.4.371.
43. Hyland ME, Sodergren SC (1996) Development of a new type of global quality of life scale and comparison and preference for 12 global scales. Qual Life Res 5(5):469-480. doi:10.1007/BF00540019.
44. Sloan A, O'Fallon JR, Suman VJ (1998) Incorporating quality of life measurement into oncology clinical trials. Proc Am Stat Assoc, pp 282-287.
45. Wewers ME, Lowe NK (1990) A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health 13:227-236. doi:10.1002/nur.4770130405.
46. Grunberg SM, Groshen S, Steingass S, Zaretsky S, Meyerowitz B (1996) Comparison of conditional quality of life terminology and visual analogue scale measurements. Qual Life Res 5:65-72. doi:10.1007/BF00435970.
47. Cohen J (1988) Statistical power analysis for the behavioral sciences. Erlbaum, Hillsdale, NJ.
48. Lipsitz SR, Fitzmaurice GM, Orav EJ, Laird NM (1994) Performance of generalized estimating equations in practical situations. Biometrics 50:270-278. doi:10.2307/2533218.
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.
50. Yuan C, Attele AS, Wu JA, Liu D (1998) Modulation of American ginseng on brainstem GABAergic effects in rats. J Ethnopharmacol 62:215-222. doi:10.1016/S0378-8741(98)00066-X.
51. Lian XY, Zhang Z, Stringer JL (2005) Protective effects of ginseng components in a rodent model of neurodegeneration. Ann Neurol 57(5):642-648. doi:10.1002/ana.20450.