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Human Breast Tissue Bioavailability of Topically Applied Limonene


Phase 1
18 Years
65 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Human Breast Tissue Bioavailability of Topically Applied Limonene


Inclusion Criteria:



- Women who are 18-65 years of age

- ECOG performance status 0-1

- Normal organ and marrow function

- Women of child-bearing potential must agree to use adequate contraception

- Willing to avoid consumption and use of citrus or citrus containing products
throughout the study

- Have both breasts intact

Exclusion Criteria:

- Have had cancer(s) within the past 5 years

- Participated in another clinical interventional trial within the past 3 months

- Uncontrolled intercurrent illness

- Pregnant or breast feeding

- Unable to produce nipple aspirate fluid

- Have known allergic or sensitive reactions to skin care products, citrus or coconut
oil

- Have ongoing skin disorders such as eczema and psoriasis

Type of Study:

Interventional

Study Design:

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

breast tissue bioavailability

Outcome Description:

limonene levels in nipple aspirate fluid after 4 weeks of intervention

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Sherry Chow, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Arizona

Authority:

United States: Institutional Review Board

Study ID:

07-0375-04

NCT ID:

NCT01459172

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer prevention
  • Breast Neoplasms

Name

Location

The University of Arizona Cancer Center Tuscon, Arizona  85724-5024