Breast CancerPhase 1NCT01046929
Limonene Study in Women With Breast Cancer
A Phase 1 study testing limonene in people with Breast Cancer, run by University of Arizona at 1 site in United States.
Trial summary
Limonene is a major component in the essential oils of citrus fruits. It has demonstrated promising breast cancer preventive and therapeutic effects in preclinical model systems. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- limonene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Mar 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are 18 years of age or older
- Women electing to undergo excision surgery for early stage breast cancer
- A minimum of 2 weeks from enrollment to definitive surgery
- Underwent core needle biopsy for breast cancer diagnosis
- No clinical evidence of metastatic breast cancer
- ECOG performance status 0-1
Show all 9Show fewer
- Participants must have normal organ and marrow function
- Women of child-bearing potential must agree to use adequate contraception
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Concurrent chemotherapy or radiation therapy
- Use of selective estrogen receptor modifiers or aromatase inhibitors within the past 3 months or concurrently
- History of other malignancies within the past 5 years excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment
- Participated in another clinical intervention trial within the past 3 months
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breast-feeding women
- Use of dietary supplement that contains large amounts of d-limonene (such as Heartburn Free with ROH10 and CoQ with d-limonene) within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Limonene in Women With a Recent Diagnosis of Early Stage Breast Cancer Electing to Undergo Excision Surgery
Limonene is a major component in the essential oils of citrus fruits. It has demonstrated promising breast cancer preventive and therapeutic effects in preclinical model systems. This early phase clinical study will evaluate the distribution of limonene to the breast tissue and its associated biological activities after 2 to 6 weeks of limonene dosing in women with a recent diagnosis of early stage breast cancer. This study will help evaluate the potentials of developing limonene as a breast cancer preventive agent.
- Conditions
- Breast Cancer
- Being tested
- limonene
- Keywords
- limonene, breast cancer, 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.
limoneneDietary supplement
oral dosing at 2 gram QD
| Study group | Role | What they receive |
|---|---|---|
| limonene | Experimental | Not described Receives: Dietary Supplement: limonene |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast tissue limonene level
Measured: 2 - 6 weeks
Secondary outcomes (1)
drug effect biomarkers in the breast tissue and serum
Measured: 2 - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionMar 2011
- Study completionMar 2011
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.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sherry Chow, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046929
- Sponsor's protocol ID
- UAz 09-0447-04
- Other IDs
- 1R21CA123033-01A2
- Status last verified
- Oct 2017
- First submitted
- 8 Jan 2010
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Limonene in Women With a Recent Diagnosis of Early Stage Breast Cancer Electing to Undergo Excision Surgery
- ClinicalTrials.gov ID
- NCT01046929
- Acronym / sponsor ID
- UAz 09-0447-04
- Conditions
- Breast Cancer
- Keywords
- limonene, breast cancer, cancer prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Jan 2010 (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.
Limonene is a major component in the essential oils of citrus fruits. It has demonstrated promising breast cancer preventive and therapeutic effects in preclinical model systems. This early phase clinical study will evaluate the distribution of limonene to the breast tissue and its associated biological activities after 2 to 6 weeks of limonene dosing in women with a recent diagnosis of early stage breast cancer. This study will help evaluate the potentials of developing limonene as a breast cancer preventive agent.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| limonene | Experimental | Dietary Supplement: limonene |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women who are 18 years of age or older
- Women electing to undergo excision surgery for early stage breast cancer
- A minimum of 2 weeks from enrollment to definitive surgery
- Underwent core needle biopsy for breast cancer diagnosis
- No clinical evidence of metastatic breast cancer
Key exclusion criteria (7 listed)
- Concurrent chemotherapy or radiation therapy
- Use of selective estrogen receptor modifiers or aromatase inhibitors within the past 3 months or concurrently
- History of other malignancies within the past 5 years excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment
- Participated in another clinical intervention trial within the past 3 months
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| limoneneoral dosing at 2 gram QD | Dietary supplement | limonene |
Primary outcome
breast tissue limonene level
Time frame: 2 - 6 weeks
1 secondary outcome
drug effect biomarkers in the breast tissue and serum
Time frame: 2 - 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 27 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 9 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 27 Oct 2017. 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 limonene level (time frame: 2 - 6 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 27 Oct 2017.