Breast CancerPhase 1NCT01459172
Human Breast Tissue Bioavailability of Topically Applied Limonene
A Phase 1 study testing limonene containing massage oil in people with Breast Cancer, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- limonene containing massage oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- limonene containing massage oil
- Keywords
- breast cancer prevention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limonene containing massage oilOther
daily massage application to the breast for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Limonene intervention | Experimental | Not described Receives: Other: limonene containing massage oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast tissue bioavailability
limonene levels in nipple aspirate fluid after 4 weeks of intervention
Measured: 4 weeks
Secondary outcomes (1)
safety
number of participants with adverse events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2007
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Sherry Chow, Ph.D., Principal investigator, The University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459172
- Sponsor's protocol ID
- 07-0375-04
- Status last verified
- Oct 2011
- First submitted
- 20 Oct 2011
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Breast Tissue Bioavailability of Topically Applied Limonene
- ClinicalTrials.gov ID
- NCT01459172
- Acronym / sponsor ID
- 07-0375-04
- Conditions
- Breast Cancer
- Keywords
- breast cancer prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Limonene intervention | Experimental | Other: limonene containing massage oil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| limonene containing massage oildaily massage application to the breast for 4 weeks | Other | Limonene intervention |
Primary outcome
breast tissue bioavailability
Time frame: 4 weeks
limonene levels in nipple aspirate fluid after 4 weeks of intervention
1 secondary outcome
safety
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry Chow, Ph.D. principal investigator
The University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing limonene containing massage oil in people with Breast Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast tissue bioavailability (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.