Human Breast Tissue Bioavailability of Topically Applied Limonene
Phase 1
Completed
- Conditions
- Breast Cancer
- Interventions
- Other: limonene containing massage oil
- Registration Number
- NCT01459172
- Lead Sponsor
- University of Arizona
- Brief Summary
The overall objective of this project is to determine the safety and breast tissue bioavailability of limonene following massage application of limonene containing massage oil to the breast.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 103
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Limonene intervention limonene containing massage oil -
- Primary Outcome Measures
Name Time Method breast tissue bioavailability 4 weeks limonene levels in nipple aspirate fluid after 4 weeks of intervention
- Secondary Outcome Measures
Name Time Method safety 6 weeks number of participants with adverse events
Trial Locations
- Locations (1)
The University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States