NauseaPhase 2/3NCT00040742

Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

A Phase 2/3 study testing ginger in people with Nausea and Vomiting, run by Gary Morrow at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Nausea, Vomiting
What is being tested?: ginger
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 745 participants
Where: 19 sitesUnited States
Study dates: Mar 2003to Dec 2011
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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:

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

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

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

Other trials in United States

About this study

Official title: A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer

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.

Read the 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.

Placebo: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
0.5g Ginger: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
1.0g Ginger: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
1.5g Ginger: 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.

Conditions: Nausea, Vomiting
Being tested: ginger, placebo
Keywords: nausea, vomiting
Medical subject headings: Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gingerDietary supplement
Given orally
placeboOther
Given orally

Study groups in NCT00040742
Study group	Role	What they receive
Placebo	Placebo comparator	Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. Receives: Other: placebo
0.5g ginger	Experimental	Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. Receives: Dietary Supplement: ginger; Other: placebo
1.0g ginger	Experimental	Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. Receives: Dietary Supplement: ginger; Other: placebo
1.5g ginger	Experimental	Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3. Receives: Dietary Supplement: ginger

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline of Peak Acute Nausea
Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings.
Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure.
Negative values for this outcome are favorable.
Measured: 3-4 days on study drug

Secondary outcomes (1)

Average Nausea Severity
Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the average of the Day 1 Evening and Night nausea ratings.
Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of average acute nausea used as the outcome measure.
Negative values for this outcome are favorable.
Measured: 3-4 days on study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2003Dec 2011

First posted27 Jan 2003 (estimated)
Study startMar 2003
Primary completionAug 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NauseaStudies of the same condition, open and under way.
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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 745 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00040742
Sponsor's protocol ID: CDR0000069401
Other IDs: U10CA037420, URCC U1902, URCC-0114
Status last verified: Oct 2015
First submitted: 8 Jul 2002
Last updated: 9 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting

All Nausea trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer
ClinicalTrials.gov ID: NCT00040742
Acronym / sponsor ID: CDR0000069401
Conditions: Nausea, Vomiting
Keywords: nausea, vomiting
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 745 participants (actual)
Lead sponsor: Gary MorrowUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Mar 2003
Primary completion: Aug 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 27 Jan 2003 (estimated)
Results: Posted 10 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Placebo: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
0.5g Ginger: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
1.0g Ginger: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
1.5g Ginger: Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Other: placeboPatients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
0.5g ginger	Experimental	Dietary Supplement: ginger, Other: placeboPatients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
1.0g ginger	Experimental	Dietary Supplement: ginger, Other: placeboPatients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
1.5g ginger	Experimental	Dietary Supplement: gingerPatients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

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
gingerGiven orally	Dietary supplement	0.5g ginger, 1.0g ginger, 1.5g ginger
placeboGiven orally	Other	0.5g ginger, 1.0g ginger, Placebo

Primary outcome

Change From Baseline of Peak Acute Nausea
Time frame: 3-4 days on study drug
Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings. Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure. Negative values for this outcome are favorable.

1 secondary outcome

Average Nausea Severity
Time frame: 3-4 days on study drug

Results and safety

Results posted to the registry on 10 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	188	149
0.5g Ginger	183	134
1.0g Ginger	187	141
1.5g Ginger	186	152

Primary outcome: Change From Baseline of Peak Acute Nausea

Time frame: 3-4 days on study drug. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 149	0.5g Ginger n = 134	1.0g Ginger n = 141	1.5g Ginger n = 152
Value	0.03 (1.85)	-0.56 (1.83)	-0.44 (1.79)	-0.15 (1.82)

Placebo vs 0.5g Ginger: Mean Difference (Final Values): -0.566, p = .017, Mixed Models Analysis
Placebo vs 1.0g Ginger: Mean Difference (Final Values): -0.506, p = 0.036, Mixed Models Analysis
Placebo vs 1.5g Ginger: Mean Difference (Final Values): -0.269, p = 0.431, Mixed Models Analysis

Population analysed: Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 188 (0%)	5 of 188 (2.7%)	Not reported
0.5g Ginger	0 of 183 (0%)	7 of 183 (3.8%)	Not reported
1.0g Ginger	1 of 187 (0.5%)	3 of 187 (1.6%)	Not reported
1.5g Ginger	0 of 187 (0%)	8 of 187 (4.3%)	Not reported

Limitations and caveats (from the sponsor): Two main weaknesses of the study, which should be controlled for in future studies, were not controlling for chemotherapy regimens (i.e., high versus low emetogenic regimens) or the severity level of nausea before enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Nausea

Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting

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.

Julie L. Ryan, PhD, MPH study chair

University of Rochester

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ginger in people with Nausea and Vomiting, run by Gary Morrow at 19 sites in United States.

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 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline of Peak Acute Nausea (time frame: 3-4 days on study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00040742.

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 9 Nov 2015.