Trial Outcomes & Findings for American Ginseng in Treating Patients With Fatigue Caused by Cancer (NCT NCT00719563)
NCT ID: NCT00719563
Last Updated: 2017-02-09
Results Overview
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
COMPLETED
PHASE3
364 participants
Baseline and week 4
2017-02-09
Participant Flow
Three-hundred and sixty-four participants were recruited between October 2008 and July 2011 from 40 North Central Cancer Treatment Group (NCCTG) member sites.
There were a total of 23 cancellations (12 Ginseng, 11 Placebo) and these 23 patients were excluded from all analysis.
Participant milestones
| Measure |
Ginseng
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
171
|
170
|
|
Overall Study
COMPLETED
|
133
|
128
|
|
Overall Study
NOT COMPLETED
|
38
|
42
|
Reasons for withdrawal
| Measure |
Ginseng
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
13
|
|
Overall Study
Medical condition changed
|
3
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
7
|
|
Overall Study
Personal reasons
|
6
|
7
|
|
Overall Study
Unknown reasons
|
4
|
6
|
|
Overall Study
Noncompliant
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
Baseline Characteristics
American Ginseng in Treating Patients With Fatigue Caused by Cancer
Baseline characteristics by cohort
| Measure |
Ginseng
n=171 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=170 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 12.7 • n=93 Participants
|
55.9 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
55.6 years
STANDARD_DEVIATION 12.2 • n=27 Participants
|
|
Gender
Female
|
138 Participants
n=93 Participants
|
128 Participants
n=4 Participants
|
266 Participants
n=27 Participants
|
|
Gender
Male
|
33 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=93 Participants
|
166 Participants
n=4 Participants
|
330 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
155 Participants
n=93 Participants
|
157 Participants
n=4 Participants
|
312 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
171 participants
n=93 Participants
|
170 participants
n=4 Participants
|
341 participants
n=27 Participants
|
|
Menopausal status
Pre
|
37 participants
n=93 Participants
|
31 participants
n=4 Participants
|
68 participants
n=27 Participants
|
|
Menopausal status
Post/natural-surgical
|
95 participants
n=93 Participants
|
90 participants
n=4 Participants
|
185 participants
n=27 Participants
|
|
Menopausal status
Not applicable (Male)
|
33 participants
n=93 Participants
|
42 participants
n=4 Participants
|
75 participants
n=27 Participants
|
|
Menopausal status
Unknown
|
6 participants
n=93 Participants
|
7 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Time since current cancer diagnosis
<180 days
|
63 participants
n=93 Participants
|
64 participants
n=4 Participants
|
127 participants
n=27 Participants
|
|
Time since current cancer diagnosis
180-360 days
|
47 participants
n=93 Participants
|
42 participants
n=4 Participants
|
89 participants
n=27 Participants
|
|
Time since current cancer diagnosis
>360 days
|
61 participants
n=93 Participants
|
64 participants
n=4 Participants
|
125 participants
n=27 Participants
|
|
More than one primary cancer
Yes
|
40 participants
n=93 Participants
|
36 participants
n=4 Participants
|
76 participants
n=27 Participants
|
|
More than one primary cancer
No
|
131 participants
n=93 Participants
|
134 participants
n=4 Participants
|
265 participants
n=27 Participants
|
|
Type of cancer
Breast
|
110 participants
n=93 Participants
|
96 participants
n=4 Participants
|
206 participants
n=27 Participants
|
|
Type of cancer
Colon
|
20 participants
n=93 Participants
|
17 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
Type of cancer
Prostate
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Type of cancer
Hematologic
|
8 participants
n=93 Participants
|
9 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Type of cancer
Gynecologic
|
5 participants
n=93 Participants
|
7 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Type of cancer
Combination/unknown/other
|
22 participants
n=93 Participants
|
33 participants
n=4 Participants
|
55 participants
n=27 Participants
|
|
Currently receiving treatment
Yes
|
83 participants
n=93 Participants
|
83 participants
n=4 Participants
|
166 participants
n=27 Participants
|
|
Currently receiving treatment
No
|
88 participants
n=93 Participants
|
87 participants
n=4 Participants
|
175 participants
n=27 Participants
|
|
Current endocrine therapy
Tamoxifen
|
23 participants
n=93 Participants
|
22 participants
n=4 Participants
|
45 participants
n=27 Participants
|
|
Current endocrine therapy
Aromatase inhibitor
|
27 participants
n=93 Participants
|
33 participants
n=4 Participants
|
60 participants
n=27 Participants
|
|
Current endocrine therapy
Antiandrogen
|
2 participants
n=93 Participants
|
5 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Current endocrine therapy
Other
|
7 participants
n=93 Participants
|
3 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Current endocrine therapy
None
|
112 participants
n=93 Participants
|
107 participants
n=4 Participants
|
219 participants
n=27 Participants
|
|
Sleep aids
Yes
|
43 participants
n=93 Participants
|
29 participants
n=4 Participants
|
72 participants
n=27 Participants
|
|
Sleep aids
No
|
128 participants
n=93 Participants
|
141 participants
n=4 Participants
|
269 participants
n=27 Participants
|
|
If taking sleep aids, how frequent?
Daily
|
18 participants
n=93 Participants
|
16 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
If taking sleep aids, how frequent?
Intermittent
|
25 participants
n=93 Participants
|
13 participants
n=4 Participants
|
38 participants
n=27 Participants
|
|
If taking sleep aids, how frequent?
Not taking sleep aids
|
128 participants
n=93 Participants
|
141 participants
n=4 Participants
|
269 participants
n=27 Participants
|
|
Exercising regularly
Yes
|
71 participants
n=93 Participants
|
68 participants
n=4 Participants
|
139 participants
n=27 Participants
|
|
Exercising regularly
No
|
98 participants
n=93 Participants
|
98 participants
n=4 Participants
|
196 participants
n=27 Participants
|
|
Exercising regularly
Missing
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
6 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 4Population: Includes all participants who completed both baseline and week 4 assessments.
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Outcome measures
| Measure |
Ginseng
n=147 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=153 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Change From Baseline to Week 4 in the General Subscale of the MFSI-SF
|
14.4 units on a scale
Standard Deviation 27.1
|
8.2 units on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: Week 1 to Week 8Population: Includes all participants that reported at least one value after baseline.
Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
Outcome measures
| Measure |
Ginseng
n=168 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=169 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence
Grade 2 Insomnia
|
9 participants
|
10 participants
|
|
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence
Grade 2 Nausea
|
5 participants
|
3 participants
|
|
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence
Grade 2 Vomiting
|
2 participants
|
2 participants
|
|
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence
Grade 3 Insomnia
|
1 participants
|
1 participants
|
|
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence
Grade 2 Anxiety
|
4 participants
|
5 participants
|
|
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence
Grade 2 Agitation
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Includes all participants who completed both baseline and week 4 assessments.
Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Outcome measures
| Measure |
Ginseng
n=147 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=152 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Mental
|
2.0 units on a scale
Standard Deviation 15.2
|
0.6 units on a scale
Standard Deviation 16.1
|
|
Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Physical
|
1.6 units on a scale
Standard Deviation 15.9
|
-0.4 units on a scale
Standard Deviation 14.7
|
|
Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Emotional
|
0.5 units on a scale
Standard Deviation 16.1
|
0.5 units on a scale
Standard Deviation 16.7
|
|
Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Vigor
|
1.8 units on a scale
Standard Deviation 19.0
|
0.4 units on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Includes all participants who completed both baseline and week 4 assessments.
Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Outcome measures
| Measure |
Ginseng
n=150 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=150 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Fatigue Worst
|
11.8 units on a scale
Standard Deviation 25.6
|
9.7 units on a scale
Standard Deviation 25.3
|
|
Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Fatigue Usual
|
11.9 units on a scale
Standard Deviation 25.7
|
9.9 units on a scale
Standard Deviation 23.4
|
|
Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Fatigue Now
|
11.8 units on a scale
Standard Deviation 26.4
|
7.9 units on a scale
Standard Deviation 24.1
|
|
Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
BFT Total Interference
|
9.2 units on a scale
Standard Deviation 22.0
|
5.8 units on a scale
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Includes all participants who completed both baseline and week 4 assessments.
Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Outcome measures
| Measure |
Ginseng
n=139 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=142 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS
Vigor/Activity
|
5.0 units on a scale
Standard Deviation 18.7
|
3.9 units on a scale
Standard Deviation 17.3
|
|
Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS
Fatigue/Inertial
|
14.5 units on a scale
Standard Deviation 25.0
|
7.7 units on a scale
Standard Deviation 23.6
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Includes all participants who completed both baseline and week 4 assessments.
PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Outcome measures
| Measure |
Ginseng
n=148 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=148 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)
|
-3.1 units on a scale
Standard Deviation 11.1
|
-3.2 units on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline and week 8Population: Includes all participants who completed both baseline and week 8 assessments.
Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.
Outcome measures
| Measure |
Ginseng
n=138 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=133 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
General
|
20 units on a scale
Standard Deviation 27.0
|
10.3 units on a scale
Standard Deviation 26.1
|
|
Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Physical
|
3.0 units on a scale
Standard Deviation 17.9
|
-1.7 units on a scale
Standard Deviation 18.2
|
|
Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Mental
|
2.8 units on a scale
Standard Deviation 16.5
|
3.4 units on a scale
Standard Deviation 15.2
|
|
Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Emotional
|
3.0 units on a scale
Standard Deviation 17.4
|
2.3 units on a scale
Standard Deviation 17.4
|
|
Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Vigor
|
4.6 units on a scale
Standard Deviation 20.5
|
2.5 units on a scale
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Includes all participants who completed both baseline and week 8 assessments.
Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.
Outcome measures
| Measure |
Ginseng
n=138 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=136 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Fatigue Usual
|
16.4 units on a scale
Standard Deviation 23.9
|
11.5 units on a scale
Standard Deviation 23.8
|
|
Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Fatigue Now
|
17.6 units on a scale
Standard Deviation 27.1
|
8.1 units on a scale
Standard Deviation 26.7
|
|
Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Fatigue Worst
|
16.6 units on a scale
Standard Deviation 27.2
|
10.0 units on a scale
Standard Deviation 26.9
|
|
Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
BFI Total Interference
|
12.9 units on a scale
Standard Deviation 25.6
|
9.0 units on a scale
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: Baseline and week 8Population: Includes all participants who completed both baseline and week 8 assessments.
Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.
Outcome measures
| Measure |
Ginseng
n=132 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=128 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS
Vigor/Activity
|
8.2 units on a scale
Standard Deviation 19.8
|
6.4 units on a scale
Standard Deviation 19.8
|
|
Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS
Fatigue/Inertia
|
18.6 units on a scale
Standard Deviation 24.8
|
10.2 units on a scale
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Includes all participants who completed both baseline and week 8 assessments.
PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.
Outcome measures
| Measure |
Ginseng
n=138 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=131 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)
|
-5.2 units on a scale
Standard Deviation 11.7
|
-4.7 units on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Includes all participants who completed both baseline and week 4 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 4.
Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).
Outcome measures
| Measure |
Ginseng
n=25 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=24 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF General
|
38.8 units on a scale
Standard Deviation 23.3
|
29.2 units on a scale
Standard Deviation 21.5
|
|
Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF Physical
|
12.2 units on a scale
Standard Deviation 18.3
|
5.7 units on a scale
Standard Deviation 15.1
|
|
Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF Mental
|
8.9 units on a scale
Standard Deviation 18.8
|
2.6 units on a scale
Standard Deviation 14.9
|
|
Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF Emotional
|
8.0 units on a scale
Standard Deviation 14.4
|
8.7 units on a scale
Standard Deviation 16.8
|
|
Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF Vigor
|
13.4 units on a scale
Standard Deviation 22.6
|
12.0 units on a scale
Standard Deviation 13.8
|
|
Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
BFI Total Interference
|
27.3 units on a scale
Standard Deviation 23.7
|
22.3 units on a scale
Standard Deviation 15.2
|
|
Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
LASA Fatigue
|
40.9 units on a scale
Standard Deviation 27.0
|
37.0 units on a scale
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Includes all participants who completed both baseline and week 8 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 8.
Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).
Outcome measures
| Measure |
Ginseng
n=34 Participants
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=35 Participants
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF General
|
35.7 units on a scale
Standard Deviation 24.7
|
30.6 units on a scale
Standard Deviation 22.5
|
|
Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF Physical
|
7.6 units on a scale
Standard Deviation 17.5
|
3.8 units on a scale
Standard Deviation 20.8
|
|
Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF Mental
|
5.3 units on a scale
Standard Deviation 19.0
|
5.3 units on a scale
Standard Deviation 16.1
|
|
Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF Emotional
|
9.8 units on a scale
Standard Deviation 14.8
|
9.8 units on a scale
Standard Deviation 15.9
|
|
Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
MFSI-SF Vigor
|
18.0 units on a scale
Standard Deviation 18.5
|
12.6 units on a scale
Standard Deviation 13.2
|
|
Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
BFI Total Interference
|
30.6 units on a scale
Standard Deviation 23.5
|
20.9 units on a scale
Standard Deviation 20.5
|
|
Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
LASA Fatigue
|
41.8 units on a scale
Standard Deviation 19.5
|
38.1 units on a scale
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: The analysis was not able to be done due to the low numbers of minorities accrued.
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Outcome measures
Outcome data not reported
Adverse Events
Ginseng
Placebo
Serious adverse events
| Measure |
Ginseng
n=168 participants at risk
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=169 participants at risk
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/168
|
1.2%
2/169 • Number of events 3
|
Other adverse events
| Measure |
Ginseng
n=168 participants at risk
Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
Placebo
n=169 participants at risk
Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
1.2%
2/168 • Number of events 3
|
0.00%
0/169
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Cardiac disorders
Sinus tachycardia
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Ear and labyrinth disorders
Tinnitus
|
0.60%
1/168 • Number of events 4
|
0.00%
0/169
|
|
Eye disorders
Dry eye syndrome
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
1/168 • Number of events 1
|
0.59%
1/169 • Number of events 1
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
2/168 • Number of events 2
|
0.00%
0/169
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/168
|
0.59%
1/169 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/168
|
0.59%
1/169 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
32.7%
55/168 • Number of events 119
|
30.2%
51/169 • Number of events 101
|
|
Gastrointestinal disorders
Tooth disorder
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
12/168 • Number of events 18
|
13.0%
22/169 • Number of events 33
|
|
General disorders
Fatigue
|
1.8%
3/168 • Number of events 4
|
2.4%
4/169 • Number of events 6
|
|
General disorders
Fever
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Investigations
Leukocyte count decreased
|
2.4%
4/168 • Number of events 6
|
0.59%
1/169 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
3.6%
6/168 • Number of events 9
|
0.00%
0/169
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/168
|
1.2%
2/169 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/168
|
0.59%
1/169 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.60%
1/168 • Number of events 1
|
0.59%
1/169 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Nervous system disorders
Tremor
|
0.00%
0/168
|
0.59%
1/169 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
16.7%
28/168 • Number of events 54
|
21.9%
37/169 • Number of events 96
|
|
Psychiatric disorders
Anxiety
|
23.8%
40/168 • Number of events 84
|
26.6%
45/169 • Number of events 110
|
|
Psychiatric disorders
Insomnia
|
47.6%
80/168 • Number of events 205
|
48.5%
82/169 • Number of events 218
|
|
Renal and urinary disorders
Urinary frequency
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.60%
1/168 • Number of events 2
|
0.00%
0/169
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/168
|
1.2%
2/169 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/168
|
0.59%
1/169 • Number of events 2
|
|
Vascular disorders
Flushing
|
0.60%
1/168 • Number of events 1
|
0.00%
0/169
|
|
Vascular disorders
Hot flashes
|
0.60%
1/168 • Number of events 1
|
1.8%
3/169 • Number of events 7
|
|
Vascular disorders
Hypertension
|
0.60%
1/168 • Number of events 1
|
0.59%
1/169 • Number of events 1
|
Additional Information
Debra L. Barton, RN, PhD, AOCN, FAAN
University of Michigan School of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place