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Limonene Study in Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sherry Chow, University of Arizona
ClinicalTrials.gov Identifier:
NCT01046929
First received: January 8, 2010
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Dietary Supplement: limonene
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • breast tissue limonene level [ Time Frame: 2 - 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • drug effect biomarkers in the breast tissue and serum [ Time Frame: 2 - 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: limonene Dietary Supplement: limonene
oral dosing at 2 gram QD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046929

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
  More Information

No publications provided

Responsible Party: Sherry Chow, Research Professor of Medicine, University of Arizona
ClinicalTrials.gov Identifier: NCT01046929     History of Changes
Other Study ID Numbers: UAz 09-0447-04, 1R21CA123033-01A2
Study First Received: January 8, 2010
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
limonene
breast cancer
cancer prevention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013