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American Ginseng in Treating Patients With Fatigue Caused by Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00719563
First received: July 18, 2008
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: July 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were a total of 23 cancellations (12 Ginseng, 11 Placebo) and these 23 patients were excluded from all analysis.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Ginseng   Placebo
STARTED   171   170 
COMPLETED   133   128 
NOT COMPLETED   38   42 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Ginseng   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 171   170   341 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.3  (12.7)   55.9  (11.8)   55.6  (12.2) 
Gender 
[Units: Participants]
     
Female   138   128   266 
Male   33   42   75 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   1   4 
Not Hispanic or Latino   164   166   330 
Unknown or Not Reported   4   3   7 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   2   3 
Asian   1   3   4 
Native Hawaiian or Other Pacific Islander   2   0   2 
Black or African American   10   8   18 
White   155   157   312 
More than one race   0   0   0 
Unknown or Not Reported   2   0   2 
Region of Enrollment 
[Units: Participants]
     
United States   171   170   341 
Menopausal status 
[Units: 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 
[Units: Participants]
     
<180 days   63   64   127 
180-360 days   47   42   89 
>360 days   61   64   125 
More than one primary cancer 
[Units: Participants]
     
Yes   40   36   76 
No   131   134   265 
Type of cancer 
[Units: 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 
[Units: Participants]
     
Yes   83   83   166 
No   88   87   175 
Current endocrine therapy 
[Units: Participants]
     
Tamoxifen   23   22   45 
Aromatase inhibitor   27   33   60 
Antiandrogen   2   5   7 
Other   7   3   10 
None   112   107   219 
Sleep aids 
[Units: Participants]
     
Yes   43   29   72 
No   128   141   269 
If taking sleep aids, how frequent? 
[Units: Participants]
     
Daily   18   16   34 
Intermittent   25   13   38 
Not taking sleep aids   128   141   269 
Exercising regularly 
[Units: Participants]
     
Yes   71   68   139 
No   98   98   196 
Missing   2   4   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 4 in the General Subscale of the MFSI-SF   [ Time Frame: Baseline and week 4 ]

2.  Secondary:   Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence   [ Time Frame: Week 1 to Week 8 ]

3.  Secondary:   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   [ Time Frame: Baseline and Week 4 ]

4.  Secondary:   Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue   [ Time Frame: Baseline and Week 4 ]

5.  Secondary:   Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS   [ Time Frame: Baseline and Week 4 ]

6.  Secondary:   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   [ Time Frame: Baseline and week 8 ]

7.  Secondary:   Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue   [ Time Frame: Baseline and Week 8 ]

8.  Secondary:   Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS   [ Time Frame: Baseline and week 8 ]

9.  Secondary:   Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations   [ Time Frame: Baseline and Week 4 ]

10.  Secondary:   Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)   [ Time Frame: Baseline and Week 4 ]
Results not yet reported.   Anticipated Reporting Date:   07/2015   Safety Issue:   No

11.  Secondary:   Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)   [ Time Frame: Baseline and Week 8 ]
Results not yet reported.   Anticipated Reporting Date:   07/2015   Safety Issue:   No

12.  Secondary:   Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3   [ Time Frame: Baseline and Week 4 ]
Results not yet reported.   Anticipated Reporting Date:   07/2015   Safety Issue:   No

13.  Secondary:   Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3   [ Time Frame: Baseline and Week 8 ]
Results not yet reported.   Anticipated Reporting Date:   07/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Debra L. Barton, RN, PhD, AOCN, FAAN
Organization: University of Michigan School of Nursing
phone: 734-763-3868
e-mail: 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.


Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00719563     History of Changes
Other Study ID Numbers: NCCTG-N07C2
NCI-2009-00872 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000597665 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: July 18, 2008
Results First Received: July 14, 2014
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration