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Limonene Study in Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01046929
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sherry Chow, University of Arizona

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: limonene Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Study of Limonene in Women With a Recent Diagnosis of Early Stage Breast Cancer Electing to Undergo Excision Surgery
Study Start Date : August 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: limonene Dietary Supplement: limonene
oral dosing at 2 gram QD


Outcome Measures
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Primary Outcome Measures :
  1. breast tissue limonene level [ Time Frame: 2 - 6 weeks ]

Secondary Outcome Measures :
  1. drug effect biomarkers in the breast tissue and serum [ Time Frame: 2 - 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046929


Locations
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United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
More Information
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Responsible Party: Sherry Chow, Research Professor of Medicine, University of Arizona
ClinicalTrials.gov Identifier: NCT01046929    
Other Study ID Numbers: UAz 09-0447-04
1R21CA123033-01A2 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Sherry Chow, University of Arizona:
limonene
breast cancer
cancer prevention
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases