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Fish oil may ease joint pain from breast cancer pills

NCT ID NCT04268134

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether taking omega-3 fatty acid supplements can reduce joint pain and stiffness caused by aromatase inhibitors, a common hormone therapy for breast cancer. 77 postmenopausal women with early-stage breast cancer or at high risk took omega-3 supplements soon after starting their medication. The goal was to see if this approach helps patients stick with their treatment by easing side effects.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

77 people

The number who actually took part.

Started

Jul 2020

Finished

Feb 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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. * 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. Exclusion Criteria * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.