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American Ginseng in Treating Patients With Fatigue Caused by Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00719563
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : August 6, 2014
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Chronic Myeloproliferative Disorders
Fatigue
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Precancerous Condition
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: American ginseng
Other: placebo
Enrollment 364
Recruitment Details Three-hundred and sixty-four participants were recruited between October 2008 and July 2011 from 40 North Central Cancer Treatment Group (NCCTG) member sites.
Pre-assignment Details There were a total of 23 cancellations (12 Ginseng, 11 Placebo) and these 23 patients were excluded from all analysis.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 171 170
Completed 133 128
Not Completed 38 42
Reason Not Completed
Adverse Event             16             13
Medical condition changed             3             5
Lack of Efficacy             3             7
Personal reasons             6             7
Unknown reasons             4             6
Noncompliant             1             1
Lost to Follow-up             5             3
Arm/Group Title Ginseng Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 171 170 341
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants 170 participants 341 participants
55.3  (12.7) 55.9  (11.8) 55.6  (12.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Female
138
  80.7%
128
  75.3%
266
  78.0%
Male
33
  19.3%
42
  24.7%
75
  22.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Hispanic or Latino
3
   1.8%
1
   0.6%
4
   1.2%
Not Hispanic or Latino
164
  95.9%
166
  97.6%
330
  96.8%
Unknown or Not Reported
4
   2.3%
3
   1.8%
7
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
American Indian or Alaska Native
1
   0.6%
2
   1.2%
3
   0.9%
Asian
1
   0.6%
3
   1.8%
4
   1.2%
Native Hawaiian or Other Pacific Islander
2
   1.2%
0
   0.0%
2
   0.6%
Black or African American
10
   5.8%
8
   4.7%
18
   5.3%
White
155
  90.6%
157
  92.4%
312
  91.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.2%
0
   0.0%
2
   0.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 171 participants 170 participants 341 participants
171 170 341
Menopausal status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Pre 37 31 68
Post/natural-surgical 95 90 185
Not applicable (Male) 33 42 75
Unknown 6 7 13
Time since current cancer diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
<180 days 63 64 127
180-360 days 47 42 89
>360 days 61 64 125
More than one primary cancer  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Yes 40 36 76
No 131 134 265
Type of cancer  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Breast 110 96 206
Colon 20 17 37
Prostate 6 8 14
Hematologic 8 9 17
Gynecologic 5 7 12
Combination/unknown/other 22 33 55
Currently receiving treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Yes 83 83 166
No 88 87 175
Current endocrine therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Tamoxifen 23 22 45
Aromatase inhibitor 27 33 60
Antiandrogen 2 5 7
Other 7 3 10
None 112 107 219
Sleep aids  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Yes 43 29 72
No 128 141 269
If taking sleep aids, how frequent?  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Daily 18 16 34
Intermittent 25 13 38
Not taking sleep aids 128 141 269
Exercising regularly  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Yes 71 68 139
No 98 98 196
Missing 2 4 6
1.Primary Outcome
Title Change From Baseline to Week 4 in the General Subscale of the MFSI-SF
Hide Description 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.
Time Frame Baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed both baseline and week 4 assessments.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 147 153
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.4  (27.1) 8.2  (24.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ginseng, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0737
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
2.Secondary Outcome
Title Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence
Hide Description 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.
Time Frame Week 1 to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants that reported at least one value after baseline.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 168 169
Measure Type: Number
Unit of Measure: participants
Grade 2 Nausea 5 3
Grade 2 Vomiting 2 2
Grade 2 Insomnia 9 10
Grade 3 Insomnia 1 1
Grade 2 Anxiety 4 5
Grade 2 Agitation 2 4
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed both baseline and week 4 assessments.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 147 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical 1.6  (15.9) -0.4  (14.7)
Mental 2.0  (15.2) 0.6  (16.1)
Emotional 0.5  (16.1) 0.5  (16.7)
Vigor 1.8  (19.0) 0.4  (15.5)
4.Secondary Outcome
Title Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Hide Description 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.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed both baseline and week 4 assessments.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 150 150
Mean (Standard Deviation)
Unit of Measure: units on a scale
Fatigue Usual 11.9  (25.7) 9.9  (23.4)
Fatigue Now 11.8  (26.4) 7.9  (24.1)
Fatigue Worst 11.8  (25.6) 9.7  (25.3)
BFT Total Interference 9.2  (22.0) 5.8  (21.1)
5.Secondary Outcome
Title Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS
Hide Description 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.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed both baseline and week 4 assessments.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 139 142
Mean (Standard Deviation)
Unit of Measure: units on a scale
Vigor/Activity 5.0  (18.7) 3.9  (17.3)
Fatigue/Inertial 14.5  (25.0) 7.7  (23.6)
6.Secondary Outcome
Title Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)
Hide Description 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.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed both baseline and week 4 assessments.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 148 148
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.1  (11.1) -3.2  (10.5)
7.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed both baseline and week 8 assessments.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 138 133
Mean (Standard Deviation)
Unit of Measure: units on a scale
General 20  (27.0) 10.3  (26.1)
Physical 3.0  (17.9) -1.7  (18.2)
Mental 2.8  (16.5) 3.4  (15.2)
Emotional 3.0  (17.4) 2.3  (17.4)
Vigor 4.6  (20.5) 2.5  (17.6)
8.Secondary Outcome
Title Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed both baseline and week 8 assessments.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 138 136
Mean (Standard Deviation)
Unit of Measure: units on a scale
Fatigue Usual 16.4  (23.9) 11.5  (23.8)
Fatigue Now 17.6  (27.1) 8.1  (26.7)
Fatigue Worst 16.6  (27.2) 10.0  (26.9)
BFI Total Interference 12.9  (25.6) 9.0  (23.0)
9.Secondary Outcome
Title Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS
Hide Description 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.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed both baseline and week 8 assessments.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 132 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
Vigor/Activity 8.2  (19.8) 6.4  (19.8)
Fatigue/Inertia 18.6  (24.8) 10.2  (26.1)
10.Secondary Outcome
Title Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed both baseline and week 8 assessments.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 138 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.2  (11.7) -4.7  (10.8)
11.Secondary Outcome
Title Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
Hide Description 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).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
MFSI-SF General 38.8  (23.3) 29.2  (21.5)
MFSI-SF Physical 12.2  (18.3) 5.7  (15.1)
MFSI-SF Mental 8.9  (18.8) 2.6  (14.9)
MFSI-SF Emotional 8.0  (14.4) 8.7  (16.8)
MFSI-SF Vigor 13.4  (22.6) 12.0  (13.8)
BFI Total Interference 27.3  (23.7) 22.3  (15.2)
LASA Fatigue 40.9  (27.0) 37.0  (19.0)
12.Secondary Outcome
Title Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
Hide Description 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).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
MFSI-SF General 35.7  (24.7) 30.6  (22.5)
MFSI-SF Physical 7.6  (17.5) 3.8  (20.8)
MFSI-SF Mental 5.3  (19.0) 5.3  (16.1)
MFSI-SF Emotional 9.8  (14.8) 9.8  (15.9)
MFSI-SF Vigor 18.0  (18.5) 12.6  (13.2)
BFI Total Interference 30.6  (23.5) 20.9  (20.5)
LASA Fatigue 41.8  (19.5) 38.1  (18.3)
13.Secondary Outcome
Title Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations
Hide Description 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.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was not able to be done due to the low numbers of minorities accrued.
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ginseng Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Ginseng Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ginseng Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/168 (0.60%)      5/169 (2.96%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Investigations     
Neutrophil count decreased  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Psychiatric disorders     
Agitation  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Anxiety  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Insomnia  1  0/168 (0.00%)  0 2/169 (1.18%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV3.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ginseng Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   115/168 (68.45%)      112/169 (66.27%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  2/168 (1.19%)  3 0/169 (0.00%)  0
Cardiac disorders     
Left ventricular failure  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Palpitations  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Sinus tachycardia  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Ear and labyrinth disorders     
Tinnitus  1  1/168 (0.60%)  4 0/169 (0.00%)  0
Eye disorders     
Dry eye syndrome  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/168 (0.60%)  1 1/169 (0.59%)  1
Colonic obstruction  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Diarrhea  1  2/168 (1.19%)  2 0/169 (0.00%)  0
Dyspepsia  1  0/168 (0.00%)  0 1/169 (0.59%)  2
Flatulence  1  0/168 (0.00%)  0 1/169 (0.59%)  2
Mucositis oral  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Nausea  1  55/168 (32.74%)  119 51/169 (30.18%)  101
Tooth disorder  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Vomiting  1  12/168 (7.14%)  18 22/169 (13.02%)  33
General disorders     
Fatigue  1  3/168 (1.79%)  4 4/169 (2.37%)  6
Fever  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Immune system disorders     
Hypersensitivity  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Infections and infestations     
Abdominal infection  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Tooth infection  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Injury, poisoning and procedural complications     
Vascular access complication  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Investigations     
Leukocyte count decreased  1  4/168 (2.38%)  6 1/169 (0.59%)  1
Lymphocyte count decreased  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Neutrophil count decreased  1  6/168 (3.57%)  9 0/169 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  0/168 (0.00%)  0 2/169 (1.18%)  2
Dehydration  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Serum sodium decreased  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bone pain  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Muscle weakness  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Muscle weakness lower limb  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Nervous system disorders     
Dizziness  1  0/168 (0.00%)  0 1/169 (0.59%)  2
Headache  1  1/168 (0.60%)  1 1/169 (0.59%)  1
Neuralgia  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Peripheral sensory neuropathy  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Tremor  1  0/168 (0.00%)  0 1/169 (0.59%)  1
Psychiatric disorders     
Agitation  1  28/168 (16.67%)  54 37/169 (21.89%)  96
Anxiety  1  40/168 (23.81%)  84 45/169 (26.63%)  110
Insomnia  1  80/168 (47.62%)  205 82/169 (48.52%)  218
Renal and urinary disorders     
Urinary frequency  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  1/168 (0.60%)  2 0/169 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  0/168 (0.00%)  0 2/169 (1.18%)  5
Dry skin  1  0/168 (0.00%)  0 1/169 (0.59%)  2
Vascular disorders     
Flushing  1  1/168 (0.60%)  1 0/169 (0.00%)  0
Hot flashes  1  1/168 (0.60%)  1 3/169 (1.78%)  7
Hypertension  1  1/168 (0.60%)  1 1/169 (0.59%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Debra L. Barton, RN, PhD, AOCN, FAAN
Organization: University of Michigan School of Nursing
Phone: 734-763-3868
EMail: debbartn@umich.edu
Publications of Results:
Barton DL, Liu H, Dakhil SR, et al.: Phase III evaluation of American ginseng (panax quinquefolius) to improve cancer-related fatigue: NCCTG trial N07C2. [Abstract] J Clin Oncol 30 (Suppl 15): A-9001, 2012.
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00719563    
Other Study ID Numbers: NCCTG-N07C2
NCI-2009-00872 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000597665 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: July 18, 2008
First Posted: July 21, 2008
Results First Submitted: July 14, 2014
Results First Posted: August 6, 2014
Last Update Posted: February 9, 2017