Human Breast Tissue Bioavailability of Topically Applied Limonene

University of Arizona

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Other: limonene containing massage oil

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01459172

07-0375-04

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

Limonene intervention

Experimental group

Treatment:

Other: limonene containing massage oil