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Completed

NCT Number: NCT01459172

Human Breast Tissue Bioavailability of Topically Applied Limonene

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

limonene containing massage oil

Other

daily massage application to the breast for 4 weeks

Primary outcomes

  1. breast tissue bioavailability

    Time frame: 4 weeks

    limonene levels in nipple aspirate fluid after 4 weeks of intervention

Secondary outcomes

  1. safety

    Time frame: 6 weeks

    number of participants with adverse events

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 25, 2011
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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