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

Phase 2

Completed

• Conditions: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: ginger extract; Other: placebo

• Registration Number: NCT00064272
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief 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.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2003-07-08
• Study First Submitted QC: 2003-07-08
• Study First Posted: 2003-07-09
• Primary Completion: 2007-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm II	ginger extract	Patients receive higher-dose oral ginger twice daily.
Arm I	ginger extract	Patients receive lower-dose oral ginger twice daily.
Arm III	placebo	Patients receive oral placebo twice daily.

Primary Outcome Measures

Name	Time	Method
Most efficacious dose
Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting)
Safety

Trial Locations

Locations (6)

University of Michigan Cancer Center CCOP Research Base; 🇺🇸 Ann Arbor, Michigan, United States

MBCCOP - Our Lady of Mercy Cancer Center; 🇺🇸 Bronx, New York, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

CCOP - Grand Rapids; 🇺🇸 Grand Rapids, Michigan, United States

MBCCOP - San Juan; 🇵🇷 San Juan, Puerto Rico

CCOP - Northern Indiana CR Consortium; 🇺🇸 South Bend, Indiana, United States