Breast CancerPhase 2ALTANCT04268134
Altering Lipids for Tolerance of Aromatase Inhibitor Therapy
A Phase 2 study testing Omega-3 fatty acid supplement in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Aromatase inhibitor medications have been approved by the U.S Food and Drug Administration (FDA) for treatment of hormone receptor positive breast cancer. This treatment has been shown to be very effective for treating breast cancer. 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?
- Omega-3 fatty acid supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 27 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Female subject aged ≥ 18 years who are postmenopausal according to standard clinical criteria or who will have been receiving LHRH agonist therapy for at least 28 days prior to AI initiation.
- Stage 0-3 estrogen receptor positive (≥1%) and/or progesterone receptor positive (≥1%) breast cancer, or patients at high risk of developing breast cancer who are planning to initiate AI therapy for chemoprevention.
- Planned initiation of aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention up to 30 days following baseline visit (ok to initiate screening up to 2 months before planned baseline visit). Concurrent LHRH agonist, anti-HER2 directed therapy (e.g., trastuzumab, pertuzumab, ado-trastuzumab emtansine), and/or CDK4/6 inhibitor therapy (e.g., palbociclib, ribociclib, abemaciclib) is permitted. Prior tamoxifen and/or toremifene is permitted.
- Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer. Completion of axillary surgery as indicated (not required). For patients at high risk of breast cancer who have not been diagnosed with breast cancer, no surgery is required.
- Completion of chemotherapy, if indicated. Concurrent use of radiation therapy, LHRHa therapy, anti-HER2 therapy, PARP inhibitor, and CDK4/6 inhibitor therapy is permitted. Prior tamoxifen is permitted.
- Agree to avoid taking omega-3 fatty acid supplements from sources outside the trial during study participation.
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- ECOG Performance Status ≤ 3.
- Able to complete questionnaires in English.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Prior use of AI therapy for treatment or prevention of breast cancer.
- Use of omega-3 fatty acid supplementation during the 3 months prior to enrollment. Consumption of O3-FA through diet is permitted.
- Use of warfarin, enoxaparin, or direct oral anticoagulants within 7 days prior to registration.
- Known chronic liver disease (laboratory studies will not be assessed). Patients with hepatosteatosis, viral hepatitis, or other liver disorders who have adequate liver function according to the treating physician are permitted to enroll.
- Known symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation (EKGs will not be performed).
- History of pancreatitis.
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- Hypersensitivity to fish and/or shellfish.
- Unable to take oral medications.
- Any medical condition that would interfere with the absorption of study medication capsules.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not, in the opinion of the treating investigator, have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Omega-3 Fatty Acids, Oxylipins, and Tolerance of Aromatase Inhibitor Therapy
Aromatase inhibitor medications have been approved by the U.S Food and Drug Administration (FDA) for treatment of hormone receptor positive breast cancer. This treatment has been shown to be very effective for treating breast cancer. However, some patients have difficulty tolerating the treatment, and some even decide to stop treatment because of the side effects. Research has shown that over half of patients who had joint pain and stiffness when taking an aromatase inhibitor had an improvement in their symptoms when they took omega-3 fatty acid supplements. This study is being conducted to test whether having patients start to take an omega-3 fatty acid supplement soon after they starting taking an aromatase inhibitor medicine will reduce the likelihood that they will have bothersome symptoms.
- Conditions
- Breast Cancer
- Being tested
- Omega-3 fatty acid supplement
- Keywords
- Aromatase inhibitor, 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 acid supplementDietary supplement
Also called Lovaza
4 capsules taken by mouth each day for 24 weeks (starting at the week 12 visit).
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 fatty acid supplement | Experimental | Omega-3 ethyl esters orally daily (containing 465 mg eicosapentaenoic acid [EPA] and 375 mg docosahexaenoic acid [DHA] per capsule,supplied as 4 x 1gm capsule) Receives: Dietary Supplement: Omega-3 fatty acid supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of Total Fatty Acids for Each Polyunsaturated Fatty Acid (PUFA) Group From Start of Omega-3 Fatty Acid (O3-FA) Supplementation to 3 Months of O3-FA
Plasma oxylipins from blood samples collected at the start of O3-FA supplementation (3 months after start of Aromatase Inhibitor [AI] therapy alone) and after 3 months of AI therapy + O3-FA supplementation (6 months after start of AI therapy alone) will be quantified using solid phase extraction-liquid chromatography-electrospray ionization tandem mass spectroscopy. Oxylipins will be grouped according to PUFA substrate (linoleic acid [LA], arachidonic acid [AA], alpha-linoleic acid [ALA], eicosapentaenoid acid [EPA], and docosahexaenoic acid [DHA]). For each patient, the percentage of total fatty acids of each PUFA group will be calculated at both time points. The overall study percentage per PUFA group will be derived from the mean percentage of that PUFA group for all patients at each time point. The change in percentage between the two time points will be reported in tabular format for each PUFA group. The results reported are the change in mean results.
Measured: From start of Omega-3 Fatty Acid (O3-FA) supplementation to 3 months of O3-FA (at 6 months after start of AI therapy)
Secondary outcomes (5)
Change in Percentage of Total Fatty Acids for Each PUFA Group From Baseline to 6 Months of Aromatase Inhibitor (AI) (3 Months of AI Alone + 3 Months of AI With O3-FA Supplementation)
Plasma oxylipins from blood samples collected at baseline (before AI therapy) and at 3 months of AI therapy + O3-FA supplementation (O3-FA supplementation starts 3 months after start of AI therapy) will be quantified using solid phase extraction-liquid chromatography-electrospray ionization tandem mass spectroscopy. Oxylipins will be grouped according to PUFA substrate (LA, AA, ALA, EPA and DHA). For each patient, the percentage of total fatty acids of each PUFA group will be calculated at both time points. The overall study percentage per PUFA group will be derived from the mean percentage of that PUFA group for all patients at each time point. The change in percentage between the two time points will be reported in tabular format for each PUFA group.
Measured: At 6 months after start of AI therapy
Change in Percentage of Total Fatty Acids for Each PUFA Group From Baseline to 3 Months of AI Therapy Alone
Plasma oxylipins from blood samples collected at baseline and at 3 months after start of AI therapy alone will be quantified using solid phase extraction-liquid chromatography-electrospray ionization tandem mass spectroscopy. Oxylipins will be grouped according to PUFA substrate (LA, AA, ALA, EPA and DHA). For each patient, the percentage of total fatty acids of each PUFA group will be calculated at both time points. The overall study percentage per PUFA group will be derived from the mean percentage of that PUFA group for all patients at each time point. The change in percentage between the two time points will be reported in tabular format for each PUFA group.
Measured: At 3 months after start of AI therapy
Number of Participants Who Develop AI-associated Musculoskeletal Symptoms (AIMSS)
Patients will be considered to have developed AIMSS if any of the following apply: (1) a ≥0.22 increase in the Health Assessment Questionnaire (HAQ) score within 9 months, (2) a ≥2.0 increase in Brief Pain Inventory (BPI) average pain within 9 months, or (3) discontinuation of AI therapy within 9 months because of new or worsened musculoskeletal symptoms, assessed using a protocol-specific discontinuation form completed by the patient's provider. The HAQ assesses interference of pain with daily activities (range 0-3), with change of 0.22 defined as a clinically meaningful difference, as noted in the literature.* The BPI assesses average pain over 7 days (range 0-10), with a change of 2.0 defined as a clinically meaningful difference, as noted in the literature.* Patients whose providers specify pain as the first or second-ranked reason for discontinuation will be considered to have discontinued AI therapy because of new or worsened musculoskeletal symptoms. *See references.
Measured: Up to 9 months after start of AI therapy
Number of Participants That Discontinue AI Therapy Due to AIMSS
Patients whose providers specify pain as the first or second-ranked reason for discontinuation (in a protocol-specific discontinuation form) will be considered to have discontinued AI therapy because of new or worsened musculoskeletal symptoms.
Measured: Up to 9 months after start of AI therapy
Number of Participants That Discontinue AI Therapy Due to Toxicity.
Patients whose providers specify toxicity as the first or second-ranked reason for discontinuation (in a protocol-specific discontinuation form) will be considered to have discontinued AI therapy due to toxicity.
Measured: Up to 9 months after start of AI therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start28 Jul 2020
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynn Henry, MD, PhD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268134
- Sponsor's protocol ID
- UMCC 2019.125
- Other IDs
- HUM00171150
- Acronym
- ALTA
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2020
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolfe F, Michaud K, Strand V. Expanding the definition of clinical differences: from minimally clinically important differences to really important differences. Analyses in 8931 patients with rheumatoid arthritis. J Rheumatol. 2005 Apr;32(4):583-9.
PubMed 15801011Farrar JT, Pritchett YL, Robinson M, Prakash A, Chappell A. The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders. J Pain. 2010 Feb;11(2):109-18. doi: 10.1016/j.jpain.2009.06.007. Epub 2009 Aug 8.
PubMed 19665938
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids, Oxylipins, and Tolerance of Aromatase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT04268134
- Acronym / sponsor ID
- ALTA / UMCC 2019.125
- Conditions
- Breast Cancer
- Keywords
- Aromatase inhibitor, Omega-3 fatty acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aromatase inhibitor medications have been approved by the U.S Food and Drug Administration (FDA) for treatment of hormone receptor positive breast cancer. This treatment has been shown to be very effective for treating breast cancer. However, some patients have difficulty tolerating the treatment, and some even decide to stop treatment because of the side effects. Research has shown that over half of patients who had joint pain and stiffness when taking an aromatase inhibitor had an improvement in their symptoms when they took omega-3 fatty acid supplements. This study is being conducted to test whether having patients start to take an omega-3 fatty acid supplement soon after they starting taking an aromatase inhibitor medicine will reduce the likelihood that they will have bothersome symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega 3 fatty acid supplement | Experimental | Dietary Supplement: Omega-3 fatty acid supplementOmega-3 ethyl esters orally daily (containing 465 mg eicosapentaenoic acid [EPA] and 375 mg docosahexaenoic acid [DHA] per capsule,supplied as 4 x 1gm capsule) |
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)
- Female subject aged ≥ 18 years who are postmenopausal according to standard clinical criteria or who will have been receiving LHRH agonist therapy for at least 28 days prior to AI initiation.
- Stage 0-3 estrogen receptor positive (≥1%) and/or progesterone receptor positive (≥1%) breast cancer, or patients at high risk of developing breast cancer who are planning to initiate AI therapy for chemoprevention.
- Planned initiation of aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention up to 30 days following baseline visit (ok to initiate screening up to 2 months before planned baseline visit). Concurrent LHRH agonist, anti-HER2 directed therapy (e.g., trastuzumab, pertuzumab, ado-trastuzumab emtansine), and/or CDK4/6 inhibitor therapy (e.g., palbociclib, ribociclib, abemaciclib) is permitted. Prior tamoxifen and/or toremifene is permitted.
- Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer. Completion of axillary surgery as indicated (not required). For patients at high risk of breast cancer who have not been diagnosed with breast cancer, no surgery is required.
- Completion of chemotherapy, if indicated. Concurrent use of radiation therapy, LHRHa therapy, anti-HER2 therapy, PARP inhibitor, and CDK4/6 inhibitor therapy is permitted. Prior tamoxifen is permitted.
Key exclusion criteria (10 listed)
- Prior use of AI therapy for treatment or prevention of breast cancer.
- Use of omega-3 fatty acid supplementation during the 3 months prior to enrollment. Consumption of O3-FA through diet is permitted.
- Use of warfarin, enoxaparin, or direct oral anticoagulants within 7 days prior to registration.
- Known chronic liver disease (laboratory studies will not be assessed). Patients with hepatosteatosis, viral hepatitis, or other liver disorders who have adequate liver function according to the treating physician are permitted to enroll.
- Known symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation (EKGs will not be performed).
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 acid supplementAlso: Lovaza4 capsules taken by mouth each day for 24 weeks (starting at the week 12 visit). | Dietary supplement | Omega 3 fatty acid supplement |
Primary outcome
Change in Percentage of Total Fatty Acids for Each Polyunsaturated Fatty Acid (PUFA) Group From Start of Omega-3 Fatty Acid (O3-FA) Supplementation to 3 Months of O3-FA
Time frame: From start of Omega-3 Fatty Acid (O3-FA) supplementation to 3 months of O3-FA (at 6 months after start of AI therapy)
Plasma oxylipins from blood samples collected at the start of O3-FA supplementation (3 months after start of Aromatase Inhibitor [AI] therapy alone) and after 3 months of AI therapy + O3-FA supplementation (6 months after start of AI therapy alone) will be quantified using solid phase extraction-liquid chromatography-electrospray ionization tandem mass spectroscopy. Oxylipins will be grouped according to PUFA substrate (linoleic acid [LA], arachidonic acid [AA], alpha-linoleic acid [ALA], eicosapentaenoid acid [EPA], and docosahexaenoic acid [DHA]). For each patient, the percentage of total fatty acids of each PUFA group will be calculated at both time points. The overall study percentage per PUFA group will be derived from the mean percentage of that PUFA group for all patients at each time point. The change in percentage between the two time points will be reported in tabular format for each PUFA group. The results reported are the change in mean results.
5 secondary outcomes
Change in Percentage of Total Fatty Acids for Each PUFA Group From Baseline to 6 Months of Aromatase Inhibitor (AI) (3 Months of AI Alone + 3 Months of AI With O3-FA Supplementation)
Time frame: At 6 months after start of AI therapy
Change in Percentage of Total Fatty Acids for Each PUFA Group From Baseline to 3 Months of AI Therapy Alone
Time frame: At 3 months after start of AI therapy
Number of Participants Who Develop AI-associated Musculoskeletal Symptoms (AIMSS)
Time frame: Up to 9 months after start of AI therapy
Number of Participants That Discontinue AI Therapy Due to AIMSS
Time frame: Up to 9 months after start of AI therapy
Number of Participants That Discontinue AI Therapy Due to Toxicity.
Time frame: Up to 9 months after start of AI therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15801011Wolfe F, Michaud K, Strand V. Expanding the definition of clinical differences: from minimally clinically important differences to really important differences. Analyses in 8931 patients with rheumatoid arthritis. J Rheumatol. 2005 Apr;32(4):583-9.
- Background: PubMed 19665938Farrar JT, Pritchett YL, Robinson M, Prakash A, Chappell A. The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders. J Pain. 2010 Feb;11(2):109-18. doi: 10.1016/j.jpain.2009.06.007. Epub 2009 Aug 8.
- Individual participant dataSharing planned: No
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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.
Lynn Henry, MD, PhD principal investigator
University of Michigan Rogel Cancer Center
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 supplement in people with Breast Cancer, run by University of Michigan Rogel Cancer Center 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 10 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 6 May 2026. 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?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Percentage of Total Fatty Acids for Each Polyunsaturated Fatty Acid (PUFA) Group From Start of Omega-3 Fatty Acid (O3-FA) Supplementation to 3 Months of O3-FA (time frame: From start of Omega-3 Fatty Acid (O3-FA) supplementation to 3 months of O3-FA (at 6 months after start of AI therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04268134, which also lists 2 linked publications.
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 6 May 2026.