UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IISupportive careCompleted18 and overNCI, OtherCDR0000310163
P30CA046592, CCUM-0201, NCT00064272

Trial Description


RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.

Further Study Information



  • Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo.


  • Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.
  • Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5-HT_3 antagonist vs NK1 antagonist).

  • Arm I: Patients receive lower-dose oral ginger twice daily.
  • Arm II: Patients receive higher-dose oral ginger twice daily.
  • Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.

Eligibility Criteria


  • Histologically confirmed diagnosis of cancer
  • Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute)
  • Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only)
  • Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and meets the following criteria:
  • Agent is the same that is scheduled for the next round of chemotherapy
  • Experienced nausea and/or vomiting of any severity (delayed or acute)
  • Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy
  • No symptomatic brain metastases NOTE: *Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • No history of bleeding disorder
  • No thrombocytopenia


  • Not specified


  • Not specified


  • Able to swallow capsules
  • No gastric ulcer
  • No clinical evidence of current or impending bowel obstruction


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to understand English
  • Able to complete study questionnaires
  • No allergy to ginger


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No prior chemotherapy regimens with multiple day doses

Endocrine therapy

  • Not specified


  • No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas:
  • Total body irradiation
  • Hemi-body
  • Upper abdomen
  • Abdominal-pelvic mantle
  • Cranium (radiosurgery)
  • Craniospinal radiotherapy


  • Not specified


  • More than 1 week since prior ginger (teas, capsules, tinctures)
  • No other concurrent ginger (teas, capsules, tinctures)
  • Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed
  • No concurrent therapeutic-doses of warfarin, aspirin, or heparin
  • Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Michigan Comprehensive Cancer Center

  • National Cancer Institute
  • National Center for Complementary and Integrative Health (NCCIH)
Suzanna Zick, Study Chair

Link to the current record.
NLM Identifier NCT00064272 processed this data on January 26, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to