Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting |
| |
Authors: | Suzanna M Zick Mack T Ruffin Julia Lee Daniel P Normolle Rivka Siden Sara Alrawi Dean E Brenner |
| |
Institution: | (1) Departments of Family Medicine, University of Michigan, Ann Arbor, MI, USA;(2) Biostatistics Unit of the Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA;(3) Department of Pharmacy Services, University of Michigan, Ann Arbor, MI, USA;(4) Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA;(5) University of Michigan Medical Center, 715 E. Huron, Suite 2E, Ann Arbor, MI 48104, USA |
| |
Abstract: | 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.
This trial is registered in ClinicalTrials.gov ID: NCT00065221. |
| |
Keywords: | Ginger Apripetant Chemotherapy-induced nausea and vomiting |
本文献已被 SpringerLink 等数据库收录! |
|