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Completed

NCT Number: NCT01046929

Limonene Study in Women With Breast Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

limonene

Dietary Supplement

oral dosing at 2 gram QD

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

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2010
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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