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Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008

Sponsors and Collaborators: University of Rochester
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00040742
  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: 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.


Condition Intervention Phase
Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Drug: ginger extract
Drug: placebo
Phase II
Phase III

MedlinePlus related topics:   Cancer    Nausea and Vomiting   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:   A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 2 (approximately 3-4 weeks on study drug) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effective dose of ginger for chemotherapy-related nausea as determined by Nausea and Vomiting Diary and Symptom Inventory at course 2 (approximately 3-4 weeks on study drug) [ Designated as safety issue: No ]
  • Adverse effects of ginger as determined by Symptom Inventory, Platelet Count Form, and AE Report at course 3 [ Designated as safety issue: Yes ]
  • Efficacy of ginger on chemotherapy-related anticipatory nausea as determined by Nausea and Vomiting Diary and Symptom Inventory at course 3 (approximately 6-8 weeks on study drug) [ Designated as safety issue: No ]
  • Quality of life by Functional Assessment Cancer Therapy-General at course 3 (approximately 6-8 weeks on study drug) [ Designated as safety issue: No ]
  • Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 3 (approximately 6-8 weeks on study drug) [ Designated as safety issue: No ]

Estimated Enrollment:   706
Study Start Date:   March 2003
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: Placebo Comparator
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
Drug: placebo
Given orally
Arm II: Experimental
Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
Drug: ginger extract
Given orally
Drug: placebo
Given orally
Arm III: Experimental
Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
Drug: ginger extract
Given orally
Drug: placebo
Given orally
Arm IV: Experimental
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
Drug: ginger extract
Given orally

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.

  • Arm I: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
  • Arm II: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
  • Arm III: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
  • Arm IV: 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040742

Locations
United States, California
CCOP - Santa Rosa Memorial Hospital     Recruiting
      Santa Rosa, California, United States, 95403
      Contact: Dyon Kwon     707-521-3814     dkwon@rrmginc.com    
United States, Hawaii
MBCCOP - Hawaii     Recruiting
      Honolulu, Hawaii, United States, 96813
      Contact: Brian F. Issell, MD, FACP     808-586-3015     brian@crch.hawaii.edu    
United States, Illinois
CCOP - Central Illinois     Recruiting
      Decatur, Illinois, United States, 62526
      Contact: James L. Wade, MD     217-876-6617     jlwade3@sbcglobal.net    
MBCCOP - University of Illinois at Chicago     Recruiting
      Chicago, Illinois, United States, 60612-7323
      Contact: Judith Murray     312-355-1472     memurray@uic.edu    
United States, Kansas
CCOP - Wichita     Recruiting
      Wichita, Kansas, United States, 67214-3882
      Contact: Shaker R. Dakhil, MD, FACP     316-268-5784        
United States, Michigan
CCOP - Grand Rapids     Recruiting
      Grand Rapids, Michigan, United States, 49503
      Contact: Marianne K. Lange, MD     616-391-1230     marianne.lange@grcop.org    
CCOP - Kalamazoo     Recruiting
      Kalamazoo, Michigan, United States, 49007-3731
      Contact: Raymond S. Lord, MD     269-373-7458     rlord@wmcc.org    
United States, Minnesota
CCOP - Metro-Minnesota     Recruiting
      St. Louis Park, Minnesota, United States, 55416
      Contact: Patrick J. Flynn, MD     952-993-1517     patrick.flynn@usoncology.com    
United States, Missouri
CCOP - Kansas City     Recruiting
      Kansas City, Missouri, United States, 64131
      Contact: Rakesh Gaur, MD     816-823-0555     rgaur@saint-lukes.org    
United States, Nevada
CCOP - Nevada Cancer Research Foundation     Recruiting
      Las Vegas, Nevada, United States, 89106
      Contact: John A. Ellerton, MD, CM     702-384-0013     sncrf@hotmail.com    
United States, New York
CCOP - Hematology-Oncology Associates of Central New York     Recruiting
      East Syracuse, New York, United States, 13057
      Contact: Jeffrey J. Kirshner, MD     315-472-7504     jkirshner@hoacny.com    
CCOP - North Shore University Hospital     Recruiting
      Manhassett, New York, United States, 11030
      Contact: Vincent P. Vinciguerra, MD     516-734-8954     vvincigu@nshs.edu    
United States, North Carolina
CCOP - Southeast Cancer Control Consortium     Recruiting
      Goldsboro, North Carolina, United States, 27534-9479
      Contact: James N. Atkins, MD     336-777-3088        
United States, Ohio
CCOP - Columbus     Recruiting
      Columbus, Ohio, United States, 43215
      Contact: J. Philip Kuebler, MD, PhD     614-488-2118     kueblep@ohiohealth.com    
United States, Oregon
CCOP - Columbia River Oncology Program     Recruiting
      Portland, Oregon, United States, 97225
      Contact: Keith S. Lanier, MD     503-216-6262        
United States, South Carolina
CCOP - Greenville     Recruiting
      Greenville, South Carolina, United States, 29615
      Contact: Jeffrey K. Giguere, MD, FACP     864-241-6251        
United States, Washington
CCOP - Northwest     Recruiting
      Tacoma, Washington, United States, 98405-0986
      Contact: Lauren K. Colman, MD     253-403-5259     lauren.colman@multicare.org    
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation     Recruiting
      Marshfield, Wisconsin, United States, 54449
      Contact: Clinical Trials Office - CCOP - Marshfield Clinic Research Fou     715-389-4457        

Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)

Investigators
Study Chair:     Julie L. Ryan, PhD, MPH     University of Rochester    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000069401, URCC-U1902, URCC-0114, NCI-5857, NCI-P02-0223
First Received:   July 8, 2002
Last Updated:   October 23, 2008
ClinicalTrials.gov Identifier:   NCT00040742
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
nausea and vomiting  
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Nausea

ClinicalTrials.gov processed this record on November 20, 2008




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