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CompletedNCT01046929Updated Oct 27, 2017

Limonene Study in Women With Breast Cancer

A Phase 1 interventional study of limonene in Breast Cancer, sponsored by University of Arizona. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-27.

Sponsored by University of Arizona · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • limonene
  • breast cancer
  • cancer prevention
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 59 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    limonene

    Dietary Supplement: limonene

Interventions

  • Dietary supplementlimonene

    oral dosing at 2 gram QD

06

What researchers measure

Primary outcomes

  1. breast tissue limonene level

    Time frame: 2 - 6 weeks

Secondary outcomes

  1. drug effect biomarkers in the breast tissue and serum

    Time frame: 2 - 6 weeks

07

Study locations

1 site
  • Arizona Cancer Center
    Tucson, Arizona 85724, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01046929
Lead sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
Responsible party
Sherry Chow (Research Professor of Medicine, University of Arizona) — Principal investigator
First posted
Jan 12, 2010
Start date
Aug 2009
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Oct 27, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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