Breast CancerNCT00702858
Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
A study testing Blue Citrus in people with Breast Cancer and Joint Pain, run by Legacy Health System.
Trial summary
This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT). Another purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Joint Pain
- What is being tested?
- Blue Citrus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jun 2011
- Phase
- Interventional
- 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
- Post Menopausal - evidenced by no menses for the past 6 months or FSH level >40
- Patient complaints of musculoskeletal symptoms
- Currently taking AIT for ER positive postmenopausal breast cancer
Who cannot join
- Previously taken Blue Citrus
- Presence of bone metastasis
- Unable to complete VAS Pain Scale
- Unable to comply/complete SF 12 Quality of Life survey
- Plan to discontinue AIT in less then six months
- Unable to complete ADL scale
- Have diagnosis of fibromyalgia
- Have diagnosis of rheumatoid arthritis
About this study
Official title: Pilot, Single Center Randomized Controlled, Double-Blind, Cross Over, Intent to Treat Trial of Blue Citrus to Placebo in Those Breast Cancer Patients Receiving Aromatase Inhibitor Therapy
This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT).
Another purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves.
Read the detailed description
Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.
- Conditions
- Breast Cancer, Joint Pain
- Being tested
- Blue Citrus, Placebo
- Keywords
- Breast Cancer, Joint Pain, Aromatase Inhibitors
- Medical subject headings
- Breast Neoplasms, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue CitrusDrug
Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months
PlaceboDrug
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Blue Citrus either months 1-3 or 4-6 Receives: Drug: Blue Citrus |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
Measured: 6 months
Secondary outcomes (2)
Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo
Measured: 6 months
Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionJun 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.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie Johnson, Legacy Health System
- Investigators
- Nathalie Johnson, MD, Principal investigator, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702858
- Sponsor's protocol ID
- Blue Citrus BC-AIT-001
- Status last verified
- Aug 2013
- First submitted
- 19 Jun 2008
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Single Center Randomized Controlled, Double-Blind, Cross Over, Intent to Treat Trial of Blue Citrus to Placebo in Those Breast Cancer Patients Receiving Aromatase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT00702858
- Acronym / sponsor ID
- Blue Citrus BC-AIT-001
- Conditions
- Breast Cancer, Joint Pain
- Keywords
- Breast Cancer, Joint Pain, Aromatase Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Jun 2008 (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.
This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT).
Another purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves.
Detailed description
Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Blue CitrusBlue Citrus either months 1-3 or 4-6 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post Menopausal - evidenced by no menses for the past 6 months or FSH level >40
- Patient complaints of musculoskeletal symptoms
- Currently taking AIT for ER positive postmenopausal breast cancer
Key exclusion criteria (8 listed)
- Previously taken Blue Citrus
- Presence of bone metastasis
- Unable to complete VAS Pain Scale
- Unable to comply/complete SF 12 Quality of Life survey
- Plan to discontinue AIT in less then six months
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 |
|---|---|---|
| Blue CitrusFive 700 mg Capsules three times a day to equal 15 capsules per day for 3 months | Drug | 1 |
| PlaceboFive Placebo capsules three times a day to equal 15 capsules per day for 3 months | Drug | 2 |
Primary outcome
Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
Time frame: 6 months
2 secondary outcomes
Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo
Time frame: 6 months
Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living
Time frame: 6 months
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 28 Aug 2013.
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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.
Nathalie Johnson, MD principal investigator
Legacy Health System
Questions about this trial
What is this clinical trial studying?
A study testing Blue Citrus in people with Breast Cancer and Joint Pain, run by Legacy Health System.
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 3 inclusion and 8 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 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo (time frame: 6 months). 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 28 Aug 2013.