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

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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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Acknowledgments

This research was supported by NCI grant 1 KO7 CA102592-01, R21AT0001735 from the National Center for Complementary and Alternative Medicine (NCCAM), NCI CN-55124, and NCI U10CA74648 (CCOP Research Base). Research resources were also provided by the General Clinical Research Center of the University of Michigan (M01-RR00042). The ginger extract was generously donated by Pure Encapsulations® (Sudbury, MA).

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Authors and Affiliations

  1. Departments of Family Medicine, University of Michigan, Ann Arbor, MI, USA

    Suzanna M. Zick, Mack T. Ruffin & Sara Alrawi

  2. Biostatistics Unit of the Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA

    Julia Lee & Daniel P. Normolle

  3. Department of Pharmacy Services, University of Michigan, Ann Arbor, MI, USA

    Rivka Siden

  4. Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA

    Dean E. Brenner

  5. University of Michigan Medical Center, 715 E. Huron, Suite 2E, Ann Arbor, MI, 48104, USA

    Suzanna M. Zick

Authors
  1. Suzanna M. Zick
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  2. Mack T. Ruffin
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  3. Julia Lee
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  4. Daniel P. Normolle
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  5. Rivka Siden
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  7. Dean E. Brenner
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Corresponding author

Correspondence to Suzanna M. Zick.

Additional information

This trial is registered in ClinicalTrials.gov ID: NCT00065221.

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Zick, S.M., Ruffin, M.T., Lee, J. et al. Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting. Support Care Cancer 17, 563–572 (2009). https://doi.org/10.1007/s00520-008-0528-8

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  • DOI: https://doi.org/10.1007/s00520-008-0528-8

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