Human Breast Tissue Bioavailability of Topically Applied Limonene

NCT ID: NCT01459172

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Limonene intervention

Group Type EXPERIMENTAL

limonene containing massage oil

Intervention Type OTHER

daily massage application to the breast for 4 weeks

Interventions

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limonene containing massage oil

daily massage application to the breast for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sherry Chow, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Arizona

Locations

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The University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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07-0375-04

Identifier Type: -

Identifier Source: org_study_id

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