Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer

This study has been terminated.
(Stopped due to concerns about interaction between St. John's wort and Tamoxifen.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest NCORP Research Base
ClinicalTrials.gov Identifier:
NCT00110136
First received: May 3, 2005
Last updated: December 17, 2014
Last verified: December 2014
Results First Received: September 4, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Hot Flashes
Intervention: Drug: St. John's Wort

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was open between 3/16/2006 and 4/1/2008. The nine patients were accrued between 11/06 and 2/08.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
St. John's Wort

Patient given one 300mg St. John's Wort tablet three times per day

St. John's Wort: St. John's Wort 300mg tablet three times per day


Participant Flow:   Overall Study
    St. John's Wort  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  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.
All registered participants are used in the analysis.

Reporting Groups
  Description
St. John's Wort

Patient given one 300mg St. John's Wort tablet three times per day

St. John's Wort: St. John's Wort 300mg tablet three times per day


Baseline Measures
    St. John's Wort  
Number of Participants  
[units: participants]
  9  
Age  
[units: years]
Mean ± Standard Deviation
  55.2  ± 7.0  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     1  
Gender  
[units: participants]
 
Female     9  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
White     9  
Region of Enrollment  
[units: participants]
 
United States     9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks   [ Time Frame: Baseline and four weeks ]

2.  Secondary:   Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks   [ Time Frame: Baseline and four weeks ]

3.  Secondary:   Estimation of Toxicities While on St. John's Wort   [ Time Frame: Six weeks following baseline (four weeks of active treatment and two weeks of follow-up) ]

4.  Secondary:   Effect of St. John's Wort on Quality of Life (MCS)   [ Time Frame: Baseline and four weeks ]

5.  Secondary:   Effect of St. John's Wort on Quality of Life (PCS)   [ Time Frame: Baseline and four weeks ]

6.  Secondary:   Mood is Measured by the POMS Short Form.   [ Time Frame: Baseline and four weeks ]


  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
This study was stopped early due to concerns about the interaction between St. John's wort and tamoxifen.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Doug Case
Organization: Wake Forest CCOP Research Base
phone: (336) 716-1048
e-mail: dcase@wakehealth.edu


No publications provided


Responsible Party: Wake Forest NCORP Research Base
ClinicalTrials.gov Identifier: NCT00110136     History of Changes
Other Study ID Numbers: CCCWFU 98301, U10CA081851
Study First Received: May 3, 2005
Results First Received: September 4, 2014
Last Updated: December 17, 2014
Health Authority: United States: Food and Drug Administration