Wednesday, 04 August 2010 21:38
Cancer - Chemotherapy Induced Nausea and Vomiting (CINV)
Currently, a number of clinical trials have generated positive results that suggest that a regimen of ginger can significantly reduce the amount of nausea and vomiting during a course of chemotherapy (Pace, 1986; Sontakke, 2003; Levine et al, 2008; Ryan et al, 2009). Many patients reputedly use ginger for prevention or treatment of nausea and vomiting caused by chemotherapy for cancer (Quimby, 2007). Zindol® recently completed a successful Phase II/III clinical trial for nausea and vomiting in cancer patients undergoing chemotherapy (Ryan et. al., 2009).*
(Pace, 1986; Sontakke, 2003; Levine et al, 2008; Ryan et al, 2009). Many patients reputedly use ginger for prevention or treatment of nausea and vomiting caused by chemotherapy for cancer (Quimby, 2007).
Pace (1986), in a published nursing doctoral dissertation, studied 41 patients being treated for leukemia with cytosine arabinoside. Participants were given 10 mg intravenous Compazine® (prochlorperazine) prior to chemotherapy and every four hours for nine additional doses. Participants who received ginger had significantly less severe nausea on the day of chemotherapy and on the following day than those taking placebo capsules.
Meyer et al., 1995 compared ginger (1.5 g) to psoralen in patients receiving 8-MOP (methoxypsoralen) for extra-corporeal chemotherapy and found that the total nausea score was reduced by approximately one-third in those receiving ginger. Sontakke (2003) found that ginger worked just as effectively in controlling nausea among chemotherapy patients (n=50) as did metoclopramide. Ondansetron was found to work better than both. Additionally, Levine et al. (2008) reported that patients treated for 3 days with high protein meals with ginger experienced less nausea.
In a recent randomized, double-blind, placebo-controlled ginger trial by Zick et al. (2009) there was no improvement in CINV. 162 patients with cancer who were receiving chemotherapy and had experienced CINV during at least one previous round of chemotherapy were randomized to receive either 1.0 g ginger, 2.0 g ginger daily, or matching placebo for 3 days. All participants were receiving a 5-HT3 receptor antagonist and/or aprepitant. The primary outcome was changed in the prevalence of delayed CINV. Secondary outcomes included acute prevalence of CINV, acute and delayed severity of CINV, and assessment of blinding. There were no differences between groups in the prevalence of delayed nausea or vomiting, prevalence of acute CINV, or severity of delayed vomiting or acute nausea and vomiting (Zick et al., 2009).
In the largest completed study to date, Ryan et al. (2009) demonstrated reduced CINV severity with 3 doses of ginger supplements (0.5 g, 1.0 g, 1.5 g), compared to placebo, in 644 adults receiving chemotherapy for primarily breast, lung and alimentary cancer (90% female, mean age = 53 yrs). Patients were studied during 3 consecutive chemotherapy cycles. The first served as a baseline. During treatment cycles 2 and 3, subjects took the same dose of ginger or a placebo twice daily for six days starting three days before Day 1 of chemotherapy and continuing for 3 days after. All patients received 5-HT3 receptor antagonist anti-emetics on Day 1.
Ginger was well-tolerated and patients were 90% compliant. Analysis of covariance (ANCOVA) examined change in nausea in the four study arms on Day 1 of cycles 2 and 3. All doses of ginger significantly reduced nausea (p=0.003). The largest reduction in nausea occurred with ginger capsules containing the equivalent 0.5 g and 1.0 g of ginger. Also, time of day had a significant effect on nausea (p<0.001) with a linear decrease over 24 hours for patients using ginger.
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treate, cure or prevent disease.
References
Bhattarai, S. Tran, V.H. & Duke, C.C. (2001) The Stability of Gingerol and Shogaol in Aqueous Solutions. Journal of Pharmaceutical Sciences 90(10): 1658-1664.
Chen, C. Kuo, M.K. Wu, C.M. & Ho, C.T. (1986) Pungent Compounds of Ginger (Zingiber officinale Roscoe) Extracted by Liquid Carbon Dioxide. Journal of Agriculture and Food Chemistry 34(3): 477-480.
Chen, C., Liu, T., Liu,Y., Tseng, W., Liu, R.H., Lu, F., Lin, Y., Kuo, S., Chen, C. (2007) 6-Shogaol (Alkanone from Ginger) Induces Apoptotic Cell Death of Human Hepatoma p53 Mutant Mahlavu Subline via an Oxidative Stress-Mediated Caspase-Dependent Mechanism. Journal of Agricultural and Food Chemistry 55(3): 948-954.
Jolad, S. D., Lantz, R. C., Solyom, A. M., Chen, G. J., Bates, R. B., Timmermann, B. N. (2004) Fresh organically grown ginger (Zingiber officinale): composition and effects on LPS-induced PGE2 production. Phytochemistry 65(13): 1937-54.
Levine, M.E., Gillis, M.G., Koch, S.Y., Voss, A.C., Stern, R.M., Koch, K L. (2008) Protein and ginger for the treatment of chemotherapy-induced delayed nausea. Journal of Alternative Complementary Medicine 14(5): p. 545-51.
Manusirivithaya, S., Sripramote, M., Tangjitgamol, S., Sheanakul, C., Leelahakorn, S., Thavaramara, T., Tangcharoenpanich, K. (2004) Antiemetic effect of ginger in gynecologic oncology patients receiving cisplatin. Int J Gynecol Cancer 14(6): 1063-9.
Meyer, K., Schwartz, J., Crater, D., Keyes, B (1995) Zingiber officinale (ginger) used to prevent 8-MOP associated nausea. Dermatol Nurs 7(4): 242-4.
Pace, J.C. (1986) Oral ingestion of encapsulated ginger and reported self-care actions for the relief of chemotherapy-associated nausea and vomiting, in Dissertation Abstracts International University of Alabama.
Quimby, E. L. (2007) The use of herbal therapies in pediatric oncology patients: treating symptoms of cancer and side effects of standard therapies. J Pediatr Oncol Nurs 24(1): 35-40.
Ryan, J. L., Heckler, C., Dakhil, S. R., Kirshner, J., Flynn, P. J., Hickok, J. T., Morrow; G. R. (2009). University of Rochester Medical Center, Rochester, NY; Wichita CCOP, Witchita, KS; HOACNY CCOP, Syracuse, NY; Metro-MN CCOP, St. Louis Park, MN Ginger for chemotherapy-related nausea in cancer patients: A URCC CCOP randomized, double-blind, placebo-controlled clinical trial of 644 cancer patients. Suppl. Abstract - No. 9511 2009 ASCO Annual Meeting - Category: Patient Care - Cancer-Related, Citation: J Clin Oncol 27:15s, 2009
Sontakke, S., Thawani, V., Naik ,M.S. (2003) Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: A randomized cross-over, double blind study. Indian Journal of Pharmacology 35(1): p. 32-36.
Zick, S. M., Ruffin, M.T., Lee, J., Normolle, D. P., Siden, R., Alrawi, S, Brenner, D. E. (2009) Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting. Support Care Cancer 17(5): 563-72.
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