Human Breast Tissue Bioavailability of Topically Applied... | NCT01459172

Studies
Human Breast Tissue Bioavailability of Topically Applied Limonene

NCT01459172

Sponsor

University of Arizona

Status

Completed

Last Update Posted

Apr 21, 2016Estimated

Enrollment

103Actual

Phase

Phase 1

Conditions

Breast Cancer

Interventions

limonene containing massage oil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Feb 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Oct 20, 2011

First Submission Date that Met QC Criteria

Oct 21, 2011

First Posted Date

Oct 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Limonene intervention	Experimental		Other: limonene containing massage oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
limonene containing massage oil	Other	daily massage application to the breast for 4 weeks	Limonene intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sherry Chow, Ph.D.	The University of Arizona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Arizona Cancer Center		Tucson	Arizona	85724	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided