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Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

Phase 2
Completed
Conditions
Nausea
Vomiting
Interventions
Dietary Supplement: ginger
Other: placebo
Registration Number
NCT00040742
Lead Sponsor
Gary Morrow
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
745
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1.0g gingerplaceboPatients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
PlaceboplaceboPatients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
0.5g gingergingerPatients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
0.5g gingerplaceboPatients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
1.0g gingergingerPatients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
1.5g gingergingerPatients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
Primary Outcome Measures
NameTimeMethod
Change From Baseline of Peak Acute Nausea3-4 days on study drug

Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings.

Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure.

Negative values for this outcome are favorable.

Secondary Outcome Measures
NameTimeMethod
Average Nausea Severity3-4 days on study drug

Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the average of the Day 1 Evening and Night nausea ratings.

Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of average acute nausea used as the outcome measure.

Negative values for this outcome are favorable.

Trial Locations

Locations (19)

CCOP - Kalamazoo

🇺🇸

Kalamazoo, Michigan, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

MBCCOP - University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

MBCCOP - Hawaii

🇺🇸

Honolulu, Hawaii, United States

CCOP - Central Illinois

🇺🇸

Decatur, Illinois, United States

CCOP - Grand Rapids

🇺🇸

Grand Rapids, Michigan, United States

CCOP - Metro-Minnesota

🇺🇸

St. Louis Park, Minnesota, United States

CCOP - Kansas City

🇺🇸

Kansas City, Missouri, United States

CCOP - North Shore University Hospital

🇺🇸

Manhassett, New York, United States

CCOP - Southeast Cancer Control Consortium

🇺🇸

Goldsboro, North Carolina, United States

CCOP - Columbus

🇺🇸

Columbus, Ohio, United States

CCOP - Columbia River Oncology Program

🇺🇸

Portland, Oregon, United States

CCOP - Greenville

🇺🇸

Greenville, South Carolina, United States

CCOP - Northwest

🇺🇸

Tacoma, Washington, United States

CCOP - Marshfield Clinic Research Foundation

🇺🇸

Marshfield, Wisconsin, United States

MBCCOP - Gulf Coast

🇺🇸

Mobile, Alabama, United States

CCOP - Nevada Cancer Research Foundation

🇺🇸

Las Vegas, Nevada, United States

CCOP - Hematology-Oncology Associates of Central New York

🇺🇸

East Syracuse, New York, United States

CCOP - Upstate Carolina

🇺🇸

Spartanburg, South Carolina, United States

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