NCT00064272

Brief Summary

RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer. PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.

Trial Health

85
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

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

May 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

July 8, 2003

Last Update Submit

October 20, 2016

Conditions

Nausea and VomitingUnspecified Adult Solid Tumor, Protocol Specific

Keywords

nausea and vomitingunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (3)

  • Most efficacious dose

  • Safety

  • Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting)

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive lower-dose oral ginger twice daily.

Drug: ginger extract

Arm II

EXPERIMENTAL

Patients receive higher-dose oral ginger twice daily.

Drug: ginger extract

Arm III

PLACEBO COMPARATOR

Patients receive oral placebo twice daily.

Other: placebo

Interventions

ginger extractDRUG

Given orally

Arm IArm II
placeboOTHER

Given orally

Arm III

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of cancer * Currently receiving chemotherapy\* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute) * Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only) * Must have received at least 1 prior chemotherapy\* course containing any chemotherapeutic agent and meets the following criteria: * Agent is the same that is scheduled for the next round of chemotherapy * Experienced nausea and/or vomiting of any severity (delayed or acute) * Must be planning to receive a concurrent 5-HT\_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy * No symptomatic brain metastases NOTE: \*Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * No history of bleeding disorder * No thrombocytopenia Hepatic * Not specified Renal * Not specified Gastrointestinal * Able to swallow capsules * No gastric ulcer * No clinical evidence of current or impending bowel obstruction Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to understand English * Able to complete study questionnaires * No allergy to ginger PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior chemotherapy regimens with multiple day doses Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas: * Total body irradiation * Hemi-body * Upper abdomen * Abdominal-pelvic mantle * Cranium (radiosurgery) * Craniospinal radiotherapy Surgery * Not specified Other * More than 1 week since prior ginger (teas, capsules, tinctures) * No other concurrent ginger (teas, capsules, tinctures) * Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed * No concurrent therapeutic-doses of warfarin, aspirin, or heparin * Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

University of Michigan Cancer Center CCOP Research Base

Ann Arbor, Michigan, 48109-0725, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

MBCCOP - Our Lady of Mercy Cancer Center

The Bronx, New York, 10466, United States

Location

MBCCOP - San Juan

San Juan, 00936, 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 Zick, MPH, ND

    University of Michigan Rogel Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

May 1, 2003

Primary Completion

May 1, 2007

Last Updated

October 21, 2016

Record last verified: 2016-10

Locations

PR(1)US(5)