PMID- 19005687 OWN - NLM STAT- MEDLINE DCOM- 20090903 LR - 20240109 IS - 1433-7339 (Electronic) IS - 0941-4355 (Print) IS - 0941-4355 (Linking) VI - 17 IP - 5 DP - 2009 May TI - Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting. PG - 563-72 LID - 10.1007/s00520-008-0528-8 [doi] AB - 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. MAIN RESULTS: 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. CONCLUSIONS: 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. FAU - Zick, Suzanna M AU - Zick SM AD - Departments of Family Medicine, University of Michigan, Ann Arbor, MI, USA. szick@med.umich.edu FAU - Ruffin, Mack T AU - Ruffin MT FAU - Lee, Julia AU - Lee J FAU - Normolle, Daniel P AU - Normolle DP FAU - Siden, Rivka AU - Siden R FAU - Alrawi, Sara AU - Alrawi S FAU - Brenner, Dean E AU - Brenner DE LA - eng GR - CN-55124/CN/NCI NIH HHS/United States GR - U10 CA074648/CA/NCI NIH HHS/United States GR - M01-RR00042/RR/NCRR NIH HHS/United States GR - KO7 CA102592-01/CA/NCI NIH HHS/United States GR - M01 RR000042/RR/NCRR NIH HHS/United States GR - NCI U10CA74648/CA/NCI NIH HHS/United States GR - K07 CA102592/CA/NCI NIH HHS/United States GR - R21 AT001735/AT/NCCIH NIH HHS/United States GR - R21AT0001735/AT/NCCIH NIH HHS/United States PT - Clinical Trial, Phase II PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural DEP - 20081113 PL - Germany TA - Support Care Cancer JT - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JID - 9302957 RN - 0 (Antiemetics) RN - 0 (Antineoplastic Agents) RN - 0 (Morpholines) RN - 0 (Serotonin 5-HT3 Receptor Antagonists) RN - 0 (Serotonin Antagonists) RN - 1NF15YR6UY (Aprepitant) SB - IM MH - Adult MH - Aged MH - Antiemetics/administration & dosage/adverse effects/*therapeutic use MH - Antineoplastic Agents/*adverse effects MH - Aprepitant MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Therapy, Combination MH - Female MH - Zingiber officinale/*chemistry MH - Humans MH - Male MH - Middle Aged MH - Morpholines/therapeutic use MH - Nausea/chemically induced/*drug therapy MH - Prevalence MH - Serotonin 5-HT3 Receptor Antagonists MH - Serotonin Antagonists/therapeutic use MH - Severity of Illness Index MH - Vomiting/chemically induced/*drug therapy PMC - PMC4131259 MID - NIHMS619439 EDAT- 2008/11/14 09:00 MHDA- 2009/09/04 06:00 PMCR- 2014/08/14 CRDT- 2008/11/14 09:00 PHST- 2008/06/14 00:00 [received] PHST- 2008/10/15 00:00 [accepted] PHST- 2008/11/14 09:00 [pubmed] PHST- 2009/09/04 06:00 [medline] PHST- 2008/11/14 09:00 [entrez] PHST- 2014/08/14 00:00 [pmc-release] AID - 10.1007/s00520-008-0528-8 [doi] PST - ppublish SO - Support Care Cancer. 2009 May;17(5):563-72. doi: 10.1007/s00520-008-0528-8. Epub 2008 Nov 13.