Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2009-08-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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limonene
limonene
oral dosing at 2 gram QD
Interventions
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limonene
oral dosing at 2 gram QD
Eligibility Criteria
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Inclusion Criteria
* Women electing to undergo excision surgery for early stage breast cancer
* A minimum of 2 weeks from enrollment to definitive surgery
* Underwent core needle biopsy for breast cancer diagnosis
* No clinical evidence of metastatic breast cancer
* ECOG performance status 0-1
* Participants must have normal organ and marrow function
* Women of child-bearing potential must agree to use adequate contraception
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Use of selective estrogen receptor modifiers or aromatase inhibitors within the past 3 months or concurrently
* History of other malignancies within the past 5 years excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment
* Participated in another clinical intervention trial within the past 3 months
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breast-feeding women
* Use of dietary supplement that contains large amounts of d-limonene (such as Heartburn Free with ROH10 and CoQ with d-limonene) within the past 3 months
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Arizona
OTHER
Responsible Party
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Sherry Chow
Research Professor of Medicine
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Countries
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Other Identifiers
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UAz 09-0447-04
Identifier Type: -
Identifier Source: org_study_id