Trial Outcomes & Findings for Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer (NCT NCT00040742)
NCT ID: NCT00040742
Last Updated: 2015-11-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
745 participants
Primary outcome timeframe
3-4 days on study drug
Results posted on
2015-11-09
Participant Flow
Participant milestones
| Measure |
Placebo
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally
|
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
|
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
|
1.5g Ginger
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
188
|
183
|
187
|
186
|
|
Overall Study
COMPLETED
|
149
|
134
|
141
|
152
|
|
Overall Study
NOT COMPLETED
|
39
|
49
|
46
|
34
|
Reasons for withdrawal
| Measure |
Placebo
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally
|
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
|
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
|
1.5g Ginger
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
15
|
16
|
21
|
9
|
|
Overall Study
Withdrawal by Subject
|
7
|
15
|
10
|
13
|
|
Overall Study
Chemotoxicity
|
4
|
3
|
5
|
2
|
|
Overall Study
Incomplete Forms
|
6
|
10
|
4
|
5
|
|
Overall Study
Other medical
|
7
|
5
|
5
|
5
|
Baseline Characteristics
Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Baseline characteristics by cohort
| Measure |
Placebo
n=149 Participants
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally
|
0.5g Ginger
n=134 Participants
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
|
1.0g Ginger
n=141 Participants
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
|
1.5g Ginger
n=152 Participants
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
|
Total
n=576 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 10.62 • n=5 Participants
|
54 years
STANDARD_DEVIATION 11.58 • n=7 Participants
|
52 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
52 years
STANDARD_DEVIATION 9.86 • n=4 Participants
|
52.75 years
STANDARD_DEVIATION 10.68 • n=21 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
521 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
137 participants
n=5 Participants
|
126 participants
n=7 Participants
|
133 participants
n=5 Participants
|
142 participants
n=4 Participants
|
538 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
10 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Education
College Grad
|
60 participants
n=5 Participants
|
47 participants
n=7 Participants
|
55 participants
n=5 Participants
|
54 participants
n=4 Participants
|
216 participants
n=21 Participants
|
|
Education
H.S. Grad
|
82 participants
n=5 Participants
|
78 participants
n=7 Participants
|
81 participants
n=5 Participants
|
95 participants
n=4 Participants
|
336 participants
n=21 Participants
|
|
Education
Some/No HS
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Education
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Previous surgery
Yes
|
131 participants
n=5 Participants
|
115 participants
n=7 Participants
|
126 participants
n=5 Participants
|
129 participants
n=4 Participants
|
501 participants
n=21 Participants
|
|
Previous surgery
No
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
15 participants
n=5 Participants
|
23 participants
n=4 Participants
|
75 participants
n=21 Participants
|
|
Previous chemotherapy
Yes
|
81 participants
n=5 Participants
|
75 participants
n=7 Participants
|
85 participants
n=5 Participants
|
82 participants
n=4 Participants
|
323 participants
n=21 Participants
|
|
Previous chemotherapy
No
|
68 participants
n=5 Participants
|
57 participants
n=7 Participants
|
56 participants
n=5 Participants
|
70 participants
n=4 Participants
|
251 participants
n=21 Participants
|
|
Previous chemotherapy
Unknown
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Previous radiation therapy
Yes
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
8 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Previous radiation therapy
No
|
136 participants
n=5 Participants
|
125 participants
n=7 Participants
|
128 participants
n=5 Participants
|
144 participants
n=4 Participants
|
533 participants
n=21 Participants
|
|
Previous radiation therapy
Unknown
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Tumor site
Alimentary
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
8 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
Tumor site
Breast
|
107 participants
n=5 Participants
|
100 participants
n=7 Participants
|
103 participants
n=5 Participants
|
117 participants
n=4 Participants
|
427 participants
n=21 Participants
|
|
Tumor site
Genitourinary
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Tumor site
Gynecologic
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
5 participants
n=4 Participants
|
31 participants
n=21 Participants
|
|
Tumor site
Hematologic
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Tumor site
Lung
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
33 participants
n=21 Participants
|
|
Tumor site
Other
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Marital status
Married
|
107 participants
n=5 Participants
|
96 participants
n=7 Participants
|
103 participants
n=5 Participants
|
114 participants
n=4 Participants
|
420 participants
n=21 Participants
|
|
Marital status
Not Married
|
42 participants
n=5 Participants
|
38 participants
n=7 Participants
|
38 participants
n=5 Participants
|
38 participants
n=4 Participants
|
156 participants
n=21 Participants
|
|
Baseline average nausea, Day1
|
2.2 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.7 • n=4 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.8 • n=21 Participants
|
|
Baseline nausea at its worst
|
2.5 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 2.0 • n=4 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 2.0 • n=21 Participants
|
|
Quality of life(FACT-G)
|
72 units on a scale
STANDARD_DEVIATION 15.9 • n=5 Participants
|
72 units on a scale
STANDARD_DEVIATION 15.0 • n=7 Participants
|
71 units on a scale
STANDARD_DEVIATION 15.4 • n=5 Participants
|
72 units on a scale
STANDARD_DEVIATION 16.0 • n=4 Participants
|
72 units on a scale
STANDARD_DEVIATION 15.6 • n=21 Participants
|
PRIMARY outcome
Timeframe: 3-4 days on study drugPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=149 Participants
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally
|
0.5g Ginger
n=134 Participants
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
|
1.0g Ginger
n=141 Participants
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
|
1.5g Ginger
n=152 Participants
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
|
|---|---|---|---|---|
|
Change From Baseline of Peak Acute Nausea
|
0.03 units on a scale
Standard Deviation 1.85
|
-0.56 units on a scale
Standard Deviation 1.83
|
-0.44 units on a scale
Standard Deviation 1.79
|
-0.15 units on a scale
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: 3-4 days on study drugPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=149 Participants
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally
|
0.5g Ginger
n=134 Participants
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
|
1.0g Ginger
n=141 Participants
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
|
1.5g Ginger
n=152 Participants
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
|
|---|---|---|---|---|
|
Average Nausea Severity
|
0.03 units on a scale
Standard Error 1.58
|
-0.44 units on a scale
Standard Error 1.67
|
-0.34 units on a scale
Standard Error 1.64
|
-0.05 units on a scale
Standard Error 1.68
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.5g Ginger
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
1.0g Ginger
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
1.5g Ginger
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=188 participants at risk
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally
|
0.5g Ginger
n=183 participants at risk
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
|
1.0g Ginger
n=187 participants at risk
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
|
1.5g Ginger
n=187 participants at risk
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
|
|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/188
|
0.00%
0/183
|
0.53%
1/187
|
0.00%
0/187
|
Other adverse events
| Measure |
Placebo
n=188 participants at risk
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally
|
0.5g Ginger
n=183 participants at risk
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
|
1.0g Ginger
n=187 participants at risk
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
|
1.5g Ginger
n=187 participants at risk
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
1.1%
2/188 • Number of events 2
|
1.1%
2/183 • Number of events 2
|
0.53%
1/187 • Number of events 1
|
2.1%
4/187 • Number of events 4
|
|
Blood and lymphatic system disorders
Bleeding
|
1.1%
2/188 • Number of events 2
|
0.00%
0/183
|
0.00%
0/187
|
0.00%
0/187
|
|
Skin and subcutaneous tissue disorders
Bruising/flushing, rash
|
0.00%
0/188
|
1.1%
2/183 • Number of events 2
|
0.00%
0/187
|
1.6%
3/187 • Number of events 3
|
|
Blood and lymphatic system disorders
Blood disorders
|
0.00%
0/188
|
0.00%
0/183
|
1.1%
2/187 • Number of events 2
|
0.00%
0/187
|
|
Infections and infestations
Infection
|
0.00%
0/188
|
0.00%
0/183
|
0.00%
0/187
|
1.1%
2/187 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary disorders
|
0.53%
1/188 • Number of events 1
|
0.55%
1/183 • Number of events 1
|
0.00%
0/187
|
0.00%
0/187
|
|
Nervous system disorders
Cerebral disorders
|
0.00%
0/188
|
0.55%
1/183 • Number of events 1
|
0.00%
0/187
|
0.00%
0/187
|
|
General disorders
Weakness, dizziness, fatigue
|
0.00%
0/188
|
0.55%
1/183 • Number of events 1
|
0.00%
0/187
|
0.00%
0/187
|
Additional Information
Charles E. Heckler, PhD, MS. Research Assistant Professor
University of Rochester Medical Center
Phone: 585-273-1141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place