Back to resultsLimonene Study in Women With Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
limonene
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring limonene, breast cancer, cancer prevention
Eligibility Criteria
Inclusion Criteria:
- Women who are 18 years of age or older
- 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:
- Concurrent chemotherapy or radiation therapy
- 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
Sites / Locations
- Arizona Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
limonene
Arm Description
Outcomes
Primary Outcome Measures
breast tissue limonene level
Secondary Outcome Measures
drug effect biomarkers in the breast tissue and serum
Full Information
NCT ID
NCT01046929
First Posted
January 8, 2010
Last Updated
October 25, 2017
Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01046929
Brief Title
Limonene Study in Women With Breast Cancer
Official Title
Clinical Study of Limonene in Women With a Recent Diagnosis of Early Stage Breast Cancer Electing to Undergo Excision Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Limonene is a major component in the essential oils of citrus fruits. It has demonstrated promising breast cancer preventive and therapeutic effects in preclinical model systems. This early phase clinical study will evaluate the distribution of limonene to the breast tissue and its associated biological activities after 2 to 6 weeks of limonene dosing in women with a recent diagnosis of early stage breast cancer. This study will help evaluate the potentials of developing limonene as a breast cancer preventive agent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
limonene, breast cancer, cancer prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
limonene
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
limonene
Intervention Description
oral dosing at 2 gram QD
Primary Outcome Measure Information:
Title
breast tissue limonene level
Time Frame
2 - 6 weeks
Secondary Outcome Measure Information:
Title
drug effect biomarkers in the breast tissue and serum
Time Frame
2 - 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who are 18 years of age or older
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:
Concurrent chemotherapy or radiation therapy
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
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
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Limonene Study in Women With Breast Cancer
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