Human Breast Tissue Bioavailability of Topically Applied Limonene

April 19, 2016 updated by: University of Arizona
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Limonene intervention
Other: limonene containing massage oil
daily massage application to the breast for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast tissue bioavailability
Time Frame: 4 weeks
limonene levels in nipple aspirate fluid after 4 weeks of intervention
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety
Time Frame: 6 weeks
number of participants with adverse events
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Sherry Chow, Ph.D., The University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 21, 2011

First Posted (Estimate)

October 25, 2011

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0375-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe