Limonene Study in Women With Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/29/2017 |
| Start Date: | August 2009 |
| End Date: | March 2011 |
Clinical Study of Limonene in Women With a Recent Diagnosis of Early Stage Breast Cancer Electing to Undergo Excision Surgery
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.
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.
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
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