Human Breast Tissue Bioavailability of Topically Applied Limonene

This study has been completed.
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01459172
First received: October 20, 2011
Last updated: April 19, 2016
Last verified: October 2011
  Purpose
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 Intervention Phase
Breast Cancer
Other: limonene containing massage oil
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Human Breast Tissue Bioavailability of Topically Applied Limonene

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • breast tissue bioavailability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    limonene levels in nipple aspirate fluid after 4 weeks of intervention


Secondary Outcome Measures:
  • safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    number of participants with adverse events


Enrollment: 103
Study Start Date: October 2007
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Limonene intervention Other: limonene containing massage oil
daily massage application to the breast for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 20, 2011
Last Updated: April 19, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
breast cancer prevention

ClinicalTrials.gov processed this record on April 27, 2016