Ginger Control of Chemotherapy Induced Nausea and Vomiting
Trial of Encapsulated Ginger as a Treatment for Chemotherapy-Induced Nausea and Vomiting
1 other identifier
interventional
180
2 countries
6
Brief Summary
This is a trial to determine the safety and efficacy of ginger in reducing the prevalence and severity of chemotherapy induced nausea and vomiting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2003
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 18, 2003
CompletedFirst Posted
Study publicly available on registry
July 22, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedJanuary 25, 2008
January 1, 2008
3.6 years
July 18, 2003
January 24, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of cancer and currently receiving chemotherapy
- Currently being treated with any chemotherapeutic agent at any dose, and have experienced nausea and/or vomiting from a previous round of chemothearpy
- Scheduled to receive a 5-HT3 receptor antagonist antiemetic: ondansetron (Zofran®) granistron (Kytril®), tropisetron (Navoban®) or dolasetron mesylate (Anzemet®), palanosetron (Alozi) and/or the NK1 antagonist aprepitant (Emend)
- Must be able to swallow capsules
- Must be able to understand English or Spanish, complete questionnaires in English or Spanish
- Women of childbearing age to use appropriate birth control
You may not qualify if:
- Chemotherapy regimens with multiple-day doses
- Clinical evidence of current or impending bowel obstruction or symptomatic brain metastases
- Concurrent radiotherapy that is classified as high or intermediate risk of causing nausea and vomiting; total body irradiation, hemi-body, upper abdomen, abdominal-pelvic mantle, cranium, craniospinal irradiation
- Pregnant or lactating
- Patients with a history of a bleeding disorder(s) or those experiencing thrombocytopenia
- Currently be taking ginger or have taken ginger in the last month
- Have an allergy to ginger
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, United States
University of Michigan Cancer Center Complementary and Alternative Medicine Research Center
Ann Arbor, Michigan, 48104, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Community Clinic Oncology Program
Grand Rapids, Michigan, 49503, United States
Our Lady of Mercy Medical Center, Comprehensive Cancer Center
The Bronx, New York, 10466, United States
Community Clinic Oncology Program
San Juan, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanna M Zick, ND, MPH
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 18, 2003
First Posted
July 22, 2003
Study Start
June 1, 2003
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
January 25, 2008
Record last verified: 2008-01