Limonene Study in Women With Breast Cancer

NCT01046929 | Completed Phase 1 DMC

• 2 other identifiers: UAz 09-0447-041R21CA123033-01A2
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

limonene; breast cancer; cancer prevention

Outcome Measures

Primary Outcomes (1)

• breast tissue limonene level

  2 - 6 weeks

Secondary Outcomes (1)

• drug effect biomarkers in the breast tissue and serum

  2 - 6 weeks

Study Arms (1)

limonene

EXPERIMENTAL

Dietary Supplement: limonene

Interventions

limonene DIETARY_SUPPLEMENT

oral dosing at 2 gram QD

limonene

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Limonene

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Monoterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Medicine

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Study Start: August 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

US (1)