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Clinical Trial Summary

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.


Clinical Trial Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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. ;


Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00064272
Study type Interventional
Source University of Michigan Cancer Center
Contact
Status Completed
Phase Phase 2
Start date May 2003

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