Breast CancerPhase 2NCT00930527
Omega-3-Fatty Acid on Joint Symptoms Inducted by Aromatase Inhibitors
A Phase 2 study testing Omega-3 Fatty Acid in people with Breast Cancer, run by Columbia University at 1 site in United States.
Trial summary
There are no data regarding the use of supplements to alleviate the musculoskeletal pain and stiffness inducted by the use of aromatase inhibitors. This study is designated to test the safety and efficacy of omega 3 fatty acid supplementation to alleviate musculoskeletal pain in postmenopausal breast cancer patients. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Omega-3 Fatty Acid
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2011
- Phase
- Phase 2
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >21 years
- Postmenopausal status defined as cessation of menses for >1 year or FSH >20 mIU/mL or bilateral oophorectomy.
- History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease
- Currently taking a third-generation aromatase inhibitor for at least 3 months
- Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry
- Ongoing musculoskeletal pain/stiffness in hand and/or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months.
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- Patients must agree to refrain from use of omega-3-fatty acid from sources outside of this study
- If taking bisphosphonates, on a stable dose for at least 1 month and tolerating the dose. Patients must agree to refrain from initiating bisphosphonate use during the course of the study, therefore it is recommended that routine bone density testing be performed prior to enrollment or after completing trial.
- ECOG performance status 0-2.
- Signed informed consent
Who cannot join
- Use of omega-3-fatty acid within the past three (3) months
- Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), gout, episodes of acute monarticular arthritis clinically consistent with pseudogout, Paget's disease affecting the study joint, a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson's disease, hemochromatosis, alkaptonuria, or primary osteochondromatosis.
- History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).
- History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.
- History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.
- Allergy to, or history of significant clinical or laboratory adverse experience associated with omega-3 fatty acid
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- Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.
- Inability to understand the study procedures and/or give written informed consent.
- Alcohol use in excess of 3 mixed drinks/day.
- Corticosteroid treatment as follows:
- Use of oral corticosteroids within the previous four weeks.
- Exposure to intramuscular corticosteroids within one month prior to entering the study.
- Administration of intra-articular steroids to the study joint, within 3 months of Randomization Visit.
- Administration of intra-articular steroids to any other joint, within 3 months of Randomization Visit.
- Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.
- Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and acetaminophen) within 2 weeks of Randomization Visit or during the study.
- Implementation of any other medical therapy for arthritis within one month prior to entry.
- Other medications, unrelated to the patient's joint pain/stiffness must have been used at a stable dosage for at least 1 month. In addition, it should be anticipated that the dose of the concomitant medication will be stable during the entire treatment period.
- Participation in another clinical study with an investigational agent within the last 4 weeks.
- Exposure to omega-3-fatty acid within 3 months of Baseline Visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Randomized Phase II Study of Omega-3-Fatty Acid on Joint Symptoms Induced by Aromatase Inhibitors in Breast Cancer Patients
There are no data regarding the use of supplements to alleviate the musculoskeletal pain and stiffness inducted by the use of aromatase inhibitors. This study is designated to test the safety and efficacy of omega 3 fatty acid supplementation to alleviate musculoskeletal pain in postmenopausal breast cancer patients.
Read the detailed description
There are no data regarding the use of these supplements in other types of musculoskeletal pain and discomfort, namely AI induced joint pain and joint stiffness. Given the lack of effective treatments for AI induced joint pain/ stiffness and the safety and efficacy of omega 3 fatty acid for musculoskeletal pain, it is therefore reasonable to test the efficacy of these dietary supplements in a population of postmenopausal breast cancer patients who experience joint pain related to aromatase inhibitors. Since women with hormone receptor positive breast cancer require long term hormonal therapy, an important objective is minimizing long term side effects to enhance patient compliance and improve quality of life.
- Conditions
- Breast Cancer
- Being tested
- Omega-3 Fatty Acid
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidDietary supplement
Also called Lovaza
4g per day for 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in serum free and total estradiol levels.
Measured: At week 3
Secondary outcomes (1)
A change in the frequency of analgesics consumed
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Closed by sponsor.
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 Columbia UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Dawn L. Hershman, Columbia University
- Investigators
- Dawn Hershman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930527
- Sponsor's protocol ID
- AAAD8300
- Status last verified
- Feb 2013
- First submitted
- 29 Jun 2009
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Omega-3-Fatty Acid on Joint Symptoms Induced by Aromatase Inhibitors in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00930527
- Acronym / sponsor ID
- AAAD8300
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed by sponsor.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 30 Jun 2009 (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.
There are no data regarding the use of supplements to alleviate the musculoskeletal pain and stiffness inducted by the use of aromatase inhibitors. This study is designated to test the safety and efficacy of omega 3 fatty acid supplementation to alleviate musculoskeletal pain in postmenopausal breast cancer patients.
Detailed description
There are no data regarding the use of these supplements in other types of musculoskeletal pain and discomfort, namely AI induced joint pain and joint stiffness. Given the lack of effective treatments for AI induced joint pain/ stiffness and the safety and efficacy of omega 3 fatty acid for musculoskeletal pain, it is therefore reasonable to test the efficacy of these dietary supplements in a population of postmenopausal breast cancer patients who experience joint pain related to aromatase inhibitors. Since women with hormone receptor positive breast cancer require long term hormonal therapy, an important objective is minimizing long term side effects to enhance patient compliance and improve quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >21 years
- Postmenopausal status defined as cessation of menses for >1 year or FSH >20 mIU/mL or bilateral oophorectomy.
- History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease
- Currently taking a third-generation aromatase inhibitor for at least 3 months
- Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry
Key exclusion criteria (20 listed)
- Use of omega-3-fatty acid within the past three (3) months
- Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), gout, episodes of acute monarticular arthritis clinically consistent with pseudogout, Paget's disease affecting the study joint, a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson's disease, hemochromatosis, alkaptonuria, or primary osteochondromatosis.
- History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).
- History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.
- History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.
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 |
|---|---|---|
| Omega-3 Fatty AcidAlso: Lovaza4g per day for 3 weeks | Dietary supplement | – |
Primary outcome
A change in serum free and total estradiol levels.
Time frame: At week 3
1 secondary outcome
A change in the frequency of analgesics consumed
Time frame: At 12 weeks
Results and safety
The study was stopped early (reason given: Closed by sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
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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.
Dawn Hershman, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 Fatty Acid in people with Breast Cancer, run by Columbia University 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 10 inclusion and 20 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: stopped early, as of the sponsor's last update on 23 Jul 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Closed by sponsor.). Results are not available in the source record.
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?
A change in serum free and total estradiol levels. (time frame: At week 3). 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 23 Jul 2014.