Limonene Study in Women With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by University of Arizona. Recruitment status was Recruiting

First Received on January 8, 2010. No Changes Posted

Sponsor:	University of Arizona
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Arizona
ClinicalTrials.gov Identifier:	NCT01046929

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 I

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

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 ]

Estimated Enrollment:	40
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 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

Contacts

Contact: Sherry Chow, Ph.D.

schow@azcc.arizona.edu

Locations

United States, Arizona
Arizona Cancer Center	Recruiting
Tucson, Arizona, United States, 85724
Contact: Sherry Chow, Ph.D. schow@azcc.arizona.edu
Principal Investigator: Sherry Chow, Ph.D.

Sponsors and Collaborators

University of Arizona

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party:	H-H. Sherry Chow, Ph.D., The 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:	January 8, 2010
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 February 09, 2012