Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer - Full Text View

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	Dietary Supplement: ginger extract Other: 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.	Other: 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.	Dietary Supplement: ginger extract Given orally Other: 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.	Dietary Supplement: ginger extract Given orally Other: 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.	Dietary Supplement: 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, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36606
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, United States, 55416
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
CCOP - North Shore University Hospital
Manhassett, New York, United States, 11030
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449

Sponsors and Collaborators

University of Rochester

National Cancer Institute (NCI)

Investigators

Study Chair:

Julie L. Ryan, PhD, MPH

University of Rochester

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000069401, URCC-U1902, URCC-0114, NCI-5857, NCI-P02-0223
Study First Received:	July 8, 2002
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00040742 History of Changes
Health Authority:	United States: Federal Government

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

Additional relevant MeSH terms:

Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Nausea

ClinicalTrials.gov processed this record on May 07, 2009