Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs
      are more effective with or without ginger in treating nausea caused by chemotherapy.

      PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with
      ginger to see how well they work compared to antiemetic drugs alone in treating nausea in
      patients who are receiving chemotherapy for cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of 1 course of ginger vs placebo when administered in regimens
           containing a 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic and
           dexamethasone (or the equivalent dose of IV methylprednisolone) in controlling
           chemotherapy-related nausea at course 2 of chemotherapy in patients with cancer.

        -  Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related
           nausea in these patients.

        -  Determine the adverse effects of ginger when given 3 days before chemotherapy
           administration in these patients.

        -  Determine the adverse effects of these antiemetic regimens during the 4 days after
           chemotherapy.

        -  Compare the chemotherapy-related anticipatory nausea in patients treated with these
           antiemetic regimens.

        -  Compare the quality of life during the 4 days after chemotherapy in patients treated
           with these antiemetic regimens.

        -  Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients
           after 2 courses of ginger vs placebo.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to participating center. Patients are randomized to 1 of 4 treatment
      arms. Day 1 of each course is defined as the day of chemotherapy administration.

        -  Placebo: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy
           courses 2 and 3.

        -  0.5g Ginger: Patients receive oral low-dose ginger and oral placebo twice daily on days
           -3 to 3 of chemotherapy courses 2 and 3.

        -  1.0g Ginger: Patients receive oral intermediate-dose ginger and oral placebo twice daily
           on days -3 to 3 of chemotherapy courses 2 and 3.

        -  1.5g Ginger: Patients receive oral high-dose ginger twice daily on days -3 to 3 of
           chemotherapy courses 2 and 3.

      Patients in each arm also continue receiving their scheduled antiemetic regimen comprising a
      5-hydroxytryptamine type-3 (5-HT3) receptor antagonist (ondansetron, granisetron,
      tropisetron, and dolasetron mesylate) and dexamethasone (DM) (or the equivalent dose of IV
      methylprednisolone (MePRDL)) on day 1 of courses 2 and 3.

      Symptoms are assessed on day -3 to day 1 of courses 2 and 3 and on days 1-4 of courses 1-3.

      Quality of life is assessed on day 4 of courses 1-3.

      Nausea and vomiting are assessed 4 times daily on days 1-4 of courses 1-3.

      PROJECTED ACCRUAL: A total of 706 patients will be accrued for this study within 3 years.
    

Intervention name(s): ginger; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Given orally; Given orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: nausea; vomiting