NCT00065221

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

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2003

Typical duration for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

Enrollment Period

3.6 years

First QC Date

July 18, 2003

Last Update Submit

January 24, 2008

Conditions

Keywords

GingerPlant preparationHerbal medicineChemotherapyNausea

Interventions

GingerDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

University of Michigan Cancer Center Complementary and Alternative Medicine Research Center

Ann Arbor, Michigan, 48104, United States

Location

St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Community Clinic Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Our Lady of Mercy Medical Center, Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

Community Clinic Oncology Program

San Juan, Puerto Rico

Location

MeSH Terms

Conditions

NauseaVomiting

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanna M Zick, ND, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

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

Locations