This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Flaxseed, Aromatase Inhibitors and Breast Tumor Characteristics (FABrC)

This study has been completed.
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
AstraZeneca
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00612560
First received: February 7, 2008
Last updated: July 17, 2017
Last verified: July 2017
Results First Received: July 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Breast Cancer
Interventions: Drug: Anastrozole
Dietary Supplement: flaxseed
Drug: Placebo

  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
No text entered.

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
Arm A - Flaxseed & Active Anastrazole

25 mg flaxseed per day and 1 mg anastrozole pill per day

Anastrozole: 1 mg per day

flaxseed: 25 g per day ground

Arm B - Flaxseed

Flaxseed 25 mg per day and 1 placebo pill per day

flaxseed: 25 g per day ground

Arm C - Anastrozole

Anastrozole 1 mg pill per day

Anastrozole: 1 mg per day

Arm D - Placebo

Placebo pill 1 per day

Placebo: Placebo pill 1 per day


Participant Flow:   Overall Study
    Arm A - Flaxseed & Active Anastrazole   Arm B - Flaxseed   Arm C - Anastrozole   Arm D - Placebo
STARTED   7   7   8   6 
COMPLETED   7   7   8   6 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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 treated and eligible patients

Reporting Groups
  Description
Arm A - Flaxseed & Active Anastrazole

25 mg flaxseed per day and 1 mg anastrozole pill per day

Anastrozole: 1 mg per day

flaxseed: 25 g per day ground

Arm B - Flaxseed

Flaxseed 25 mg per day and 1 placebo pill per day

flaxseed: 25 g per day ground

Arm C - Anastrozole

Anastrozole 1 mg pill per day

Anastrozole: 1 mg per day

Arm D - Placebo

Placebo pill 1 per day

Placebo: Placebo pill 1 per day

Total Total of all reporting groups

Baseline Measures
   Arm A - Flaxseed & Active Anastrazole   Arm B - Flaxseed   Arm C - Anastrozole   Arm D - Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   8   6   28 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3  42.9%      6  85.7%      4  50.0%      3  50.0%      16  57.1% 
>=65 years      4  57.1%      1  14.3%      4  50.0%      3  50.0%      12  42.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (8.5)   58  (7.5)   65  (6.6)   64  (7.6)   62  (7.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      7 100.0%      7 100.0%      8 100.0%      6 100.0%      28 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1  14.3%      0   0.0%      0   0.0%      1   3.6% 
White      7 100.0%      6  85.7%      8 100.0%      6 100.0%      27  96.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Expression of Estrogen Receptor (ER-beta)   [ Time Frame: biopsy and surgical resection ]

2.  Primary:   Progesterone Receptor (PR) Expression   [ Time Frame: biopsy and surgical resection ]

3.  Primary:   Human Epidermal Growth Factor Receptor 2 (Her2) Expression   [ Time Frame: biopsy and surgical resection ]

4.  Secondary:   Growth Hormone Serum Levels IGF-1   [ Time Frame: biopsy and surgical resection ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00612560     History of Changes
Obsolete Identifiers: NCT00635908
Other Study ID Numbers: I 99507
I99507
R21AT004024-01 ( U.S. NIH Grant/Contract )
Study First Received: February 7, 2008
Results First Received: July 17, 2017
Last Updated: July 17, 2017