Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

Last updated: October 13, 2015
Sponsor: Gary Morrow
Overall Status: Completed

Phase

2/3

Condition

Lactose Intolerance

Colic

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT00040742
CDR0000069401
URCC U1902
URCC-0114
U10CA037420
  • Ages 18-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer and be scheduled to receive at least 3 courses of chemotherapy

  • Scheduled to receive chemotherapy with no planned interruption by radiotherapy or surgery

  • Chemotherapy courses must be separated by at least 2 weeks from day 1 to day 1 of next course

  • Must have experienced nausea of any degree of severity after completion of the first study-related course of chemotherapy

  • Received a prior 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone (DM) given at any dose and by any route (or equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of course 1 of chemotherapy

  • Scheduled to receive a 5-HT3 receptor antagonist antiemetic with DM (or equivalent dose of IV MePRDL) on day 1 of courses 2 and 3 of chemotherapy

  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count greater than 100,000/mm^3 at second course of chemotherapy

  • No prior bleeding or blood coagulation disorder (e.g., thrombocytopenia or platelet dysfunction)

Hepatic:

  • No prior coagulation factor deficiency

Renal:

  • Not specified

Cardiovascular:

  • No prior vascular defect

Other:

  • Able to understand English

  • No concurrent or impending bowel obstruction

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent interferon therapy

Chemotherapy:

  • See Disease Characteristics

  • At least 6 months since other prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent warfarin or heparin for therapeutic anticoagulation

  • Concurrent low-dose warfarin for maintenance of venous access allowed

  • Concurrent rescue medications for control of symptoms caused by the cancer or its treatment allowed as clinically indicated

Study Design

Total Participants: 745
Study Start date:
March 01, 2003
Estimated Completion Date:
December 31, 2011

Study 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.

Connect with a study center

  • MBCCOP - Gulf Coast

    Mobile, Alabama 36606
    United States

    Site Not Available

  • MBCCOP - Hawaii

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois 60612-7323
    United States

    Site Not Available

  • CCOP - Central Illinois

    Decatur, Illinois 62526
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • CCOP - Grand Rapids

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • CCOP - Kalamazoo

    Kalamazoo, Michigan 49007-3731
    United States

    Site Not Available

  • CCOP - Metro-Minnesota

    St. Louis Park, Minnesota 55416
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York 13057
    United States

    Site Not Available

  • CCOP - North Shore University Hospital

    Manhassett, New York 11030
    United States

    Site Not Available

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina 27534-9479
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43215
    United States

    Site Not Available

  • CCOP - Columbia River Oncology Program

    Portland, Oregon 97225
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • CCOP - Northwest

    Tacoma, Washington 98405-0986
    United States

    Site Not Available

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

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