Clinical Trial: Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: University of Rochester
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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: Randomized phase II/III trial to determine the effectiveness of antiemetic drugs with or without ginger in treating nausea in patients who are receiving chemotherapy for cancer.

Condition Treatment or Intervention Phase
nausea and vomiting
unspecified adult solid tumor, protocol specific
 Drug: dexamethasone
 Drug: dolasetron mesylate
 Drug: ginger
 Drug: granisetron
 Drug: methylprednisolone
 Drug: ondansetron
 Drug: tropisetron
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: herbal medicine / botanical therapy
 Procedure: nausea and vomiting therapy
 Procedure: supportive care/therapy
Phase II
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Nausea and Vomiting

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II/III Randomized Study of Ginger for Chemotherapy-Related Nausea in Patients With Cancer

Further Study Details: 

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 chemotherapy course 3 in these patients.
  • 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.

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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:

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

Location and Contact Information


Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Tom Robert Fitch, MD  480-301-9875 

      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2413    david.king@baannerhealth.com 

Colorado
      Boulder Community Hospital, Boulder,  Colorado,  80301-9019,  United States; Recruiting
John Thomas Fleagle, MD  303-440-2399 

      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States; Recruiting
Eduardo R. Pajon, MD  303-777-2663    erpajon@aol.com 

      Hope Cancer Care Center at Longmont United Hospital, Longmont,  Colorado,  80501,  United States; Recruiting
Robert Evan Fisher, MD  303-485-4132 

      Medical Center of Aurora - South Campus, Aurora,  Colorado,  80012-0000,  United States; Recruiting
Sami G. Diab, MD  303-418-7600 

      Penrose Cancer Center at Penrose Hospital, Colorado Springs,  Colorado,  80933,  United States; Recruiting
Robert Lynn Sayre, MD  719-577-2555 

      Porter Adventist Hospital, Denver,  Colorado,  80210,  United States; Recruiting
David Trevarthen, MD  303-788-8675 

      Presbyterian - St. Luke's Medical Center, Denver,  Colorado,  80218,  United States; Recruiting
Robert M. Jotte, MD, PhD  303-388-4876 

      Rocky Mountain Cancer Centers - Denver Rose, Denver,  Colorado,  80220,  United States; Recruiting
Scot M. Sedlacek, MD  303-321-0302 

      Rocky Mountain Cancer Centers - Thornton, Thornton,  Colorado,  80229,  United States; Recruiting
Alvin L. Otsuka, MD  303-386-7622    aotsuka@direcpc.com 

      Sky Ridge Medical Center, Lone Tree,  Colorado,  80124,  United States; Recruiting
Dennis Carter, MD  720-225-4200 

      St. Joseph Hospital, Denver,  Colorado,  80218-1191,  United States; Recruiting
Michael McLaughlin, MD  303-861-3302 

      St. Mary-Corwin Regional Medical Center, Pueblo,  Colorado,  81004,  United States; Recruiting
Marlow M. Sloan, MD  719-560-6000 

      Swedish Medical Center, Englewood,  Colorado,  80112,  United States; Recruiting
Marshall Davis, MD  303-788-5860 

Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Brian F. Issell, MD  808-586-3015    brian@crch.hawaii.edu 

Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6617    jlwade3@sbcglobal.net 

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
Gershon Y. Locker, MD, FACP  847-570-2518    glocker@enh.org 

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  269-373-7488    rlord@wmcc.org 

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States; Recruiting
Richard J. Rosenbluth, MD  201-996-5917 

New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Vincent P. Vinciguerra, MD  516-562-8954 

      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse,  New York,  13057,  United States; Recruiting
Jeffrey J. Kirshner, MD  315-472-7504 

North Carolina
      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
James N. Atkins, MD  336-777-3088 

Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-488-2118 

      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
Howard M. Gross, MD  937-832-1093 

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
Jeffrey Kent Giguere, MD  864-241-6251 

Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting
Lauren Kenneth Colman, MD  253-403-5259    lauren.colman@multicare.org 

Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Tarit Kumar Banerjee, MD, FACP  715-387-5511 

Study chairs or principal investigators

Jane T. Hickok, MD, MPH,  Study Chair,  James P. Wilmot Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069401; URCC-U1902; URCC-0114; NCI-5857; NCI-P02-0223; NCT00040742
Record last reviewed:  July 2004
Last Updated:  April 4, 2005
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00040742
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005