Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting.

Suzanna M Zick, Mack T Ruffin, Julia Lee, Daniel P Normolle, Rivka Siden, Sara Alrawi, Dean E Brenner
Author Information
  1. Suzanna M Zick: Departments of Family Medicine, University of Michigan, Ann Arbor, MI, USA. szick@med.umich.edu

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.

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Grants

  1. CN-55124/NCI NIH HHS
  2. U10 CA074648/NCI NIH HHS
  3. M01-RR00042/NCRR NIH HHS
  4. KO7 CA102592-01/NCI NIH HHS
  5. M01 RR000042/NCRR NIH HHS
  6. NCI U10CA74648/NCI NIH HHS
  7. K07 CA102592/NCI NIH HHS
  8. R21 AT001735/NCCIH NIH HHS
  9. R21AT0001735/NCCIH NIH HHS

MeSH Term

Adult
Aged
Antiemetics
Antineoplastic Agents
Aprepitant
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Female
Zingiber officinale
Humans
Male
Middle Aged
Morpholines
Nausea
Prevalence
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Severity of Illness Index
Vomiting

Chemicals

Antiemetics
Antineoplastic Agents
Morpholines
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Aprepitant

Word Cloud

Created with Highcharts 10.0.0CINVacutenauseavomitingdelayedgingerprevalenceGingeraprepitantParticipantsseverityefficacychemotherapy-inducedrandomizedtrialreceivingchemotherapyparticipants5-HT3receptorantagonistsand/or0gtooktreatmentAEsGOALSOFWORK:usedtreatnumeroustypesalsostudiedHoweverdiverseoncologypopulationunknownMATERIALSANDMETHODS:performeddouble-blindplacebo-controlled162patientscancerexperiencedleastonepreviousroundreceiveeither12dailymatchingplacebo3daysprimaryoutcomechangeSecondaryoutcomesincludedassessmentblindingMAINRESULTS:differencesgroupssevereableaccuratelyguessreceivedappearedwelltolerateddifferenceadverseeventssignificantlylessfatiguemiscellaneousgroupCONCLUSIONS:providesadditionalbenefitreductiongivenPhaseIIencapsulated

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