Breast Cancer
Conditions
Keywords
breast cancer prevention
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.
Interventions
OTHERlimonene containing massage oil
daily massage application to the breast for 4 weeks
Sponsors
United States Department of Defense
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| breast tissue bioavailability | 4 weeks | limonene levels in nipple aspirate fluid after 4 weeks of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety | 6 weeks | number of participants with adverse events |
Countries
United States
Outcome results
None listed