Limonene Study in Women With Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: limonene

• Registration Number: NCT01046929
• Lead Sponsor: University of Arizona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
limonene	limonene	-

Primary Outcome Measures

Name	Time	Method
breast tissue limonene level	2 - 6 weeks

Secondary Outcome Measures

Name	Time	Method
drug effect biomarkers in the breast tissue and serum	2 - 6 weeks

Trial Locations

Locations (1)

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States