NCT00064272

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

Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Nausea and Vomiting
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	ginger extract	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2003-05-01
• Primary completion: 2007-05-01
• First posted: 2003-07-09
• Last updated: 2016-10-21

Locations

6 sites across 2 countries: United States, Puerto Rico