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Human Breast Tissue Bioavailability of Topically Applied Limonene

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01459172
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : April 21, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: limonene containing massage oil Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Human Breast Tissue Bioavailability of Topically Applied Limonene
Study Start Date : October 2007
Primary Completion Date : February 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. breast tissue bioavailability [ Time Frame: 4 weeks ]
    limonene levels in nipple aspirate fluid after 4 weeks of intervention


Secondary Outcome Measures :
  1. safety [ Time Frame: 6 weeks ]
    number of participants with adverse events


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459172


Locations
United States, Arizona
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
United States Department of Defense
Investigators
Principal Investigator: Sherry Chow, Ph.D. The University of Arizona
More Information

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01459172     History of Changes
Other Study ID Numbers: 07-0375-04
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: October 2011

Keywords provided by University of Arizona:
breast cancer prevention