American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients

Among the symptoms referred by cancer patients, cancer related fatigue (CRF) is one of the most disabling symptom with a relevant impact on the quality of life. CRF can occur before, during and after anti-cancer treatment. The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in breast cancer women receiving adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* submitted for the first time to adjuvant chemotherapy with anthracyclines and cyclophosphamide after surgery for breast cancer;
* not presenting CRF or at least with o al massimo CRF lieve (NRS \< 4);
* 18 year old, who have given written informermed consent;
* who accept to use adequate contraceptive methods, if they are of child-bearing potential.

Exclusion Criteria:

* previously submitted to chemotherapy;
* with concomitant not-correctable alterations, present before chemotherapy, possible determinants of fatigue (NRS ≥ 4), such as anemia, not well controlled pain, insomnia, electrolyte imbalance, dehydration, anorexia/cachexia, hepatic, renal or heart failure, adrenocortical failure, neurological deficit, hypothyroidism, not-controlled diabetes mellitus;
* submitted to raitherapy during the 15 days before the randomization;
* presenting moderate-severe fatigue (NRS ≥ 4) at basaline;
* receivind opioids or corticosteroids (except if admimistered at phisiological doses or to prevent emesis on the chemotherapy day);
* with with blood cell count \< 3000/mm3, platelets \< 70000 mm3, hemoglobin \< 8 g/dL;
* unable to understand the procedures of the study or to collaborate with them;
* pregnant or breastfeeding.

• RESULTKoornstra RH, Peters M, Donofrio S, van den Borne B, de Jong FA. Management of fatigue in patients with cancer -- a practical overview. Cancer Treat Rev. 2014 Jul;40(6):791-9. doi: 10.1016/j.ctrv.2014.01.004. Epub 2014 Feb 7. PMID 24576643
• RESULTBarton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL. Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer. 2010 Feb;18(2):179-87. doi: 10.1007/s00520-009-0642-2. Epub 2009 May 6. PMID 19415341
• RESULTBarton DL, Liu H, Dakhil SR, Linquist B, Sloan JA, Nichols CR, McGinn TW, Stella PJ, Seeger GR, Sood A, Loprinzi CL. Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2. J Natl Cancer Inst. 2013 Aug 21;105(16):1230-8. doi: 10.1093/jnci/djt181. Epub 2013 Jul 13. PMID 23853057