NCT01459172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
Last Updated

April 21, 2016

Status Verified

October 1, 2011

Enrollment Period

2.3 years

First QC Date

October 20, 2011

Last Update Submit

April 19, 2016

Conditions

Breast Cancer

Keywords

breast cancer prevention

Outcome Measures

Primary Outcomes (1)

  • breast tissue bioavailability

    limonene levels in nipple aspirate fluid after 4 weeks of intervention

    4 weeks

Secondary Outcomes (1)

  • safety

    6 weeks

Study Arms (1)

Limonene intervention

EXPERIMENTAL
Other: limonene containing massage oil

Interventions

limonene containing massage oilOTHER

daily massage application to the breast for 4 weeks

Limonene intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sherry Chow, Ph.D.

    The University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 25, 2011

Study Start

October 1, 2007

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

April 21, 2016

Record last verified: 2011-10

Locations

US(1)