American Ginseng in Treating Patients With Fatigue Caused by Cancer

This study has been completed.
Sponsor:
Collaborator:
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  
Number of Participants  
[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
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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 posted.   Anticipated Posting 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 posted.   Anticipated Posting 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 posted.   Anticipated Posting 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 posted.   Anticipated Posting 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
No text entered.


  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


No publications provided


Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00719563     History of Changes
Other Study ID Numbers: NCCTG-N07C2, NCI-2009-00872, CDR0000597665
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