Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
This study has been completed.
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00843167
First received: February 12, 2009
Last updated: February 20, 2015
Last verified: February 2015
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Results First Received: December 30, 2014
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions: |
Breast Cancer Precancerous Condition |
| Interventions: |
Dietary Supplement: broccoli sprout extract Other: 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 |
|---|
| This clinical trial was conducted between 12/23/2008 to 3/27/2013 at Oregon Health and Science University’s (OHSU) Center for Women’s Health Breast Center in Portland, OR. English-speaking women were recruited to participate in the study based on the following inclusion criteria: ≥ 21 years, diagnostic mammogram with results that require biopsy. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Sulforaphane Supplement |
Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. broccoli sprout extract: Given orally |
| Placebo |
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. placebo: Given orally |
Participant Flow for 2 periods
Period 1: Treatment Period
| Sulforaphane Supplement | Placebo | |
|---|---|---|
| STARTED | 27 | 27 |
| COMPLETED | 24 | 19 |
| NOT COMPLETED | 3 | 8 |
| Adverse Event | 1 | 5 |
| Withdrawal by Subject | 2 | 3 |
Period 2: Follow-up
| Sulforaphane Supplement | Placebo | |
|---|---|---|
| STARTED | 24 | 24 |
| Completed Final Visit | 24 | 24 |
| COMPLETED | 24 | 24 |
| NOT COMPLETED | 0 | 0 |
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. |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Sulforaphane Supplement |
Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. broccoli sprout extract: Given orally |
| Placebo |
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. placebo: Given orally |
| Total | Total of all reporting groups |
Baseline Measures
| Sulforaphane Supplement | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
27 | 27 | 54 |
|
Age
[units: participants] |
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| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 18 | 42 |
| >=65 years | 3 | 9 | 12 |
|
Age
[units: years] Mean ± Standard Deviation |
53.5 ± 9.5 | 55.3 ± 14.3 | 54.4 ± 12.1 |
|
Gender
[units: participants] |
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| Female | 27 | 27 | 54 |
| Male | 0 | 0 | 0 |
|
Race (NIH/OMB)
[units: participants] |
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| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 26 | 24 | 50 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
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| United States | 27 | 27 | 54 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy [ Time Frame: Baseline and end of study (up to 8 weeks) ] |
| 2. Primary: | Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy [ Time Frame: Baseline and end of study (up to 8 weeks) ] |
| 3. Primary: | Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy [ Time Frame: Baseline and End of Study (up to 8 weeks) ] |
| 4. Secondary: | Treatment Compliance [ Time Frame: Baseline and end of study (up to 8 weeks) ] |
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 |
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| No text entered. |
More Information
Certain Agreements:
Results Point of Contact:
No publications provided
| 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. Jackilen Shannon
Organization: Oregon Health & Science University
phone: 541-706-6861
e-mail: shannoja@ohsu.edu
Organization: Oregon Health & Science University
phone: 541-706-6861
e-mail: shannoja@ohsu.edu
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00843167 History of Changes |
| Other Study ID Numbers: | CDR0000634111, R21CA132236, P30CA069533, OHSU-4702 |
| Study First Received: | February 12, 2009 |
| Results First Received: | December 30, 2014 |
| Last Updated: | February 20, 2015 |
| Health Authority: | United States: Federal Government |