Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting
- 1.1k Downloads
Goals of work
Ginger has been used to treat numerous types of nausea and vomiting. Ginger has also been studied for its efficacy for acute chemotherapy-induced nausea and vomiting (CINV). However, its efficacy for delayed CINV in a diverse oncology population is unknown.
Materials and methods
We performed a randomized, double-blind, placebo-controlled trial in 162 patients with cancer who were receiving chemotherapy and had experienced CINV during at least one previous round of chemotherapy. All participants were receiving a 5-HT3 receptor antagonists and/or aprepitant. Participants were randomized to receive either 1.0 g ginger, 2.0 g ginger daily, or matching placebo for 3 days. The primary outcome was change 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. Participants who took both ginger and aprepitant had more severe acute nausea than participants who took only aprepitant. Participants were able to accurately guess which treatment they had received. Ginger appeared well tolerated, with no difference in all adverse events (AEs) and significantly less fatigue and miscellaneous AEs in the ginger group.
Ginger provides no additional benefit for reduction of the prevalence or severity of acute or delayed CINV when given with 5-HT3 receptor antagonists and/or aprepitant.
KeywordsGinger Apripetant Chemotherapy-induced nausea and vomiting
- 3.Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J (2006) Delayed nausea and vomiting continue to reduce patients’ quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol 24(27):4472–4478 doi:10.1200/JCO.2006.05.6382 PubMedCrossRefGoogle Scholar
- 8.http://ctep.cancer.gov/forms/CTCAEv3.pdf. Accessed on March 25th 2008
- 10.de Wit R, Herrstedt J, Rapoport B et al (2003) Addition of the oral NK1 antagonist aprepitant to standard antiemetics provides protection against nausea and vomiting during multiple cycles of cisplatin-based chemotherapy. J Clin Oncol 21(22):4105–4111 doi:10.1200/JCO.2003.10.128 PubMedCrossRefGoogle Scholar
- 11.Fergusson D, Glass K, Waring D, Shapiro S (2004) Turning a blind eye: the success of blinding reported in a random sample of randomized, placebo controlled trials. BMJ 328:7437Google Scholar
- 12.Feyer P, Kleeberg UR, Steingraber M, Gunther W, Behrens M (2008) Frequency of side effects in outpatient cancer care and their influence on patient satisfaction—a prospective survey using the PASQOC(R) questionnaire. Support Care Cancer 16:567–575 doi:10.1007/s00520-008-0422-4 PubMedCrossRefGoogle Scholar
- 17.Hoffman D (1983) The new holistic herbal. Element Books Limited, Shaftesbury, DorsetGoogle Scholar
- 18.Huang QR, Iwamoto M, Aoki S, Tanaka N, Tajima K, Yamahara J, Takaishi Y, Yoshida M, Tomimatsu T, Tamai Y (1991) Anti-5-hydroxytryptamine3 effect of galanolactone, diterpenoid isolated from ginger. Chem Pharm Bull (Tokyo) 39(2):397–399Google Scholar
- 25.Mills S, Bone K (2000) Principles and practice of phytotherapy. Churchill Livingstone, OxfordGoogle Scholar
- 27.Ody P (1993) The complete medicinal herbal. Dorling-Kindersley, New YorkGoogle Scholar
- 28.Pace J (1987) Oral ingestion of encapsulated ginger and reported self-care action for the relief of chemotherapy-associated N & E. Dissertations Abstracts International 47:3297–BGoogle Scholar
- 29.Pecoraro A, Patel J, Guthrie T, Ndubisi B (1998) Efficacy of ginger as an adjunctive anti-emetic in acute chemotherapy-induced nausea and vomiting. ASHP Mid-Year Clinical Meeting, 429EGoogle Scholar
- 30.Platel K, Srinivasan K (2000) Influence of dietary spices and their active principles on pancreatic digestive enzymes in albino rats. Nahrung 44(1):42–46 doi:10.1002/(SICI)1521-3803(20000101)44:1<42::AID-FOOD42>3.0.CO;2-D PubMedCrossRefGoogle Scholar
- 33.Sontakke S, Thawani V, Naik MS (2003) Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: a randomized, cross-over, double-blind study. Indian J Pharmacol 35:32–36Google Scholar
- 36.Yamahara J, Huang QR, Li YH, Xu L, Fujimura H (1990) Gastrointestinal motility enhancing effect of ginger and its active constituents. Chem Pharm Bull (Tokyo) 38(2):430–431Google Scholar