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Human Breast Tissue Bioavailability of Topically Applied Limonene

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
limonene containing massage oil
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer prevention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Arizona Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Limonene intervention

Arm Description

Outcomes

Primary Outcome Measures

breast tissue bioavailability
limonene levels in nipple aspirate fluid after 4 weeks of intervention

Secondary Outcome Measures

safety
number of participants with adverse events

Full Information

First Posted
October 20, 2011
Last Updated
April 19, 2016
Sponsor
University of Arizona
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01459172
Brief Title
Human Breast Tissue Bioavailability of Topically Applied Limonene
Official Title
Human Breast Tissue Bioavailability of Topically Applied Limonene
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Limonene intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
limonene containing massage oil
Intervention Description
daily massage application to the breast for 4 weeks
Primary Outcome Measure Information:
Title
breast tissue bioavailability
Description
limonene levels in nipple aspirate fluid after 4 weeks of intervention
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
safety
Description
number of participants with adverse events
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry Chow, Ph.D.
Organizational Affiliation
The University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

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Human Breast Tissue Bioavailability of Topically Applied Limonene

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