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


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

breast tissue limonene level

Outcome Time Frame:

2 - 6 weeks

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

UAz 09-0447-04

NCT ID:

NCT01046929

Start Date:

August 2009

Completion Date:

March 2011

Related Keywords:

  • Breast Cancer
  • limonene
  • breast cancer
  • cancer prevention
  • Breast Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724