Nausea and VomitingPhase 2IRB 2003-551NCT00064272
UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
A Phase 2 study testing ginger extract in people with Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific, run by University of Michigan Rogel Cancer Center at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- ginger extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 6 sitesin 2 countries
- Study dates
- May 2003to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Michigan Cancer Center CCOP Research Base
Ann Arbor, Michigan, 48109-0725
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
MBCCOP - Our Lady of Mercy Cancer Center
The Bronx, New York, 10466
About this study
Official title: Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
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.
Read the detailed description
OBJECTIVES:
Primary
- Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo.
Secondary
- Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
- Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5-HT_3 antagonist vs NK1 antagonist).
- Arm I: Patients receive lower-dose oral ginger twice daily.
- Arm II: Patients receive higher-dose oral ginger twice daily.
- Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days.
Patients are followed at 1 week.
PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.
- Being tested
- ginger extract, placebo
- Keywords
- nausea and vomiting, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ginger extractDrug
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive lower-dose oral ginger twice daily. Receives: Drug: ginger extract |
| Arm II | Experimental | Patients receive higher-dose oral ginger twice daily. Receives: Drug: ginger extract |
| Arm III | Placebo comparator | Patients receive oral placebo twice daily. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2003 (estimated)
- Study startMay 2003
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Suzanna Zick, MPH, ND, Study chair, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064272
- Sponsor's protocol ID
- CDR0000310163
- Other IDs
- P30CA046592, CCUM-0201
- Acronym
- IRB 2003-551
- Status last verified
- Oct 2016
- First submitted
- 8 Jul 2003
- Last updated
- 21 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
- ClinicalTrials.gov ID
- NCT00064272
- Acronym / sponsor ID
- IRB 2003-551 / CDR0000310163
- Keywords
- nausea and vomiting, unspecified adult solid tumor, protocol specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- May 2003
- Primary completion
- May 2007 (actual)
- First posted
- 9 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo.
Secondary
- Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
- Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5-HT_3 antagonist vs NK1 antagonist).
- Arm I: Patients receive lower-dose oral ginger twice daily.
- Arm II: Patients receive higher-dose oral ginger twice daily.
- Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days.
Patients are followed at 1 week.
PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: ginger extractPatients receive lower-dose oral ginger twice daily. |
| Arm II | Experimental | Drug: ginger extractPatients receive higher-dose oral ginger twice daily. |
| Arm III | Placebo comparator | Other: placeboPatients receive oral placebo twice daily. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ginger extractGiven orally | Drug | Arm I, Arm II |
| placeboGiven orally | Other | Arm III |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanna Zick, MPH, ND study chair
University of Michigan Rogel Cancer Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ginger extract in people with Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific, run by University of Michigan Rogel Cancer Center at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Most efficacious dose. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.