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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA037420 | U.S. NIH Grant/Contract | View source | |
| URCC U1902 | Other Identifier | University of Rochester CCOP Research Base | |
| URCC-0114 | Other Identifier | NCI DCP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. |
|
| 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. |
|
| 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. |
|
| 1.5g ginger | Experimental | Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ginger | Dietary Supplement | Given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-4 days on study drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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DISEASE CHARACTERISTICS:
Diagnosis of cancer and be scheduled to receive at least 3 courses of chemotherapy
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Julie L. Ryan, PhD, MPH | University of Rochester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - Gulf Coast | Mobile | Alabama | 36606 | United States | ||
| MBCCOP - Hawaii |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. placebo: Given orally |
| FG001 | 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. ginger extract: Given orally placebo: Given orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Other | Given orally |
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| 3-4 days on study drug |
| Honolulu |
| Hawaii |
| 96813 |
| United States |
| MBCCOP - University of Illinois at Chicago | Chicago | Illinois | 60612-7323 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| CCOP - North Shore University Hospital | Manhassett | New York | 11030 | United States |
| CCOP - Southeast Cancer Control Consortium | Goldsboro | North Carolina | 27534-9479 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| FG002 | 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. ginger extract: Given orally placebo: Given orally |
| FG003 | 1.5g Ginger | Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3. ginger extract: Given orally |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. placebo: Given orally |
| BG001 | 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. ginger extract: Given orally placebo: Given orally |
| BG002 | 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. ginger extract: Given orally placebo: Given orally |
| BG003 | 1.5g Ginger | Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3. ginger extract: Given orally |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Education | Number | participants |
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| Previous surgery | Number | participants |
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| Previous chemotherapy | Number | participants |
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| Previous radiation therapy | Number | participants |
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| Tumor site | Number | participants |
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| Marital status | Number | participants |
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| Baseline average nausea, Day1 | Average nausea evaluated using a 7-point semantic rating scale anchored by "1" = " Not at all nauseated" and by "7" = "Extremely nauseated." | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline nausea at its worst | Maximum nausea evaluated using a 7-point semantic rating scale anchored by "1" = " Not at all nauseated" and by "7" = "Extremely nauseated." | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Quality of life(FACT-G) | Quality of life is evaluated using the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item compilation of questions divided into 4 primary domains: Physical Well-Being (PWB)[range 0 - 28], Social Well-Being (SWB)[range 0 - 28], Emotional Well-Being (EWB) [range 0 - 24], and Functional Well-Being (FWB) [range 0 - 28]. Total FACT-G score is a sum of the 4 primary domains [range 0 - 108]. The higher the score, the better. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-4 days on study drug |
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| Secondary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | 3-4 days on study drug |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. placebo: Given orally | 0 | 188 | 5 | 188 | ||
| EG001 | 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. ginger extract: Given orally placebo: Given orally | 0 | 183 | 7 | 183 | ||
| EG002 | 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. ginger extract: Given orally placebo: Given orally | 1 | 187 | 3 | 187 | ||
| EG003 | 1.5g Ginger | Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3. ginger extract: Given orally | 0 | 187 | 8 | 187 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal symptoms | Gastrointestinal disorders | Systematic Assessment |
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| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Bruising/flushing, rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Blood disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Pulmonary disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cerebral disorders | Nervous system disorders | Systematic Assessment |
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| Weakness, dizziness, fatigue | General disorders | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles E. Heckler, PhD, MS. Research Assistant Professor | University of Rochester Medical Center | 585-273-1141 | checkler@urmc.rochester.edu |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000713927 | ginger extract |
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| Male |
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| Non-White |
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| Unknown |
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| H.S. Grad |
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| Some/No HS |
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| Unknown |
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| No |
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| No |
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| Unknown |
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| No |
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| Unknown |
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| Breast |
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| Genitourinary |
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| Gynecologic |
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| Hematologic |
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| Lung |
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| Other |
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| Not Married |
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| No |
| Superiority or Other |
| H0: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea = 0. Ha: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea > 0. (Two-sided) | Mixed Models Analysis | Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used. | 0.036 | The p-value was adjusted using theTukey-Kramer method. | Mean Difference (Final Values) | -0.506 | Standard Error of the Mean | 0.141 | 2-Sided | The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group. | No | Superiority or Other |
| H0: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea = 0. Ha: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea > 0. (Two-sided) | Mixed Models Analysis | Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used. | 0.431 | The p-value was adjusted using theTukey-Kramer method. | Mean Difference (Final Values) | -0.269 | Standard Error of the Mean | 0.137 | 2-Sided | The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group. | No | Superiority or Other |
| Placebo vs. Any Ginger. H0: Mean difference between [(0.5g +1.0g +1.5g) / 3] and placebo of change from baseline of Peak Acute Nausea = 0. Ha: Mean difference between [(0.5g +1.0g +1.5g) / 3] and placebo of change from baseline of Peak Acute Nausea > 0. (Two-sided) | Mixed Models Analysis | Parameter estimated using a contrast. | 0.003 | Mean Difference (Final Values) | -0.470 | Standard Error of the Mean | 0.160 | 2-Sided | The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group. | No | Superiority or Other |
| OG003 | 1.5g Ginger | Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3. ginger extract: Given orally |
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