Limonene Study in Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Clinical Study of Limonene in Women With a Recent Diagnosis of Early Stage Breast Cancer Electing to Undergo Excision Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046929
• Other study ID #: UAz 09-0447-04
• Secondary ID: 1R21CA123033-01A
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2010
• Last updated: October 25, 2017
• Start date: August 2009
• Est. completion date: March 2011

Study information

• Verified date: October 2017
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• limonene
oral dosing at 2 gram QD

Locations

Country	Name	City	State
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast tissue limonene level		2 - 6 weeks
Secondary	drug effect biomarkers in the breast tissue and serum		2 - 6 weeks