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Clinical Trials/NCT01459172
NCT01459172CompletedPhase 1

Human Breast Tissue Bioavailability of Topically Applied Limonene

University of Arizona2 sites in 1 country103 target enrollmentStarted: October 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
103
Locations
2
Primary Endpoint
breast tissue bioavailability
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts 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

Outcomes

Primary Outcomes

breast tissue bioavailability

Time Frame: 4 weeks

limonene levels in nipple aspirate fluid after 4 weeks of intervention

Secondary Outcomes

  • safety(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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