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Fish oil and arthritis drug tested against aggressive breast cancer in young women

NCT ID NCT01881048

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested whether two anti-inflammatory drugs—fish oil (omega-3 fatty acid) and celecoxib (Celebrex)—could reduce inflammation and slow cancer growth in women aged 18-50 with pregnancy-associated breast cancer. The 42 participants took one of the drugs for at least a week before their planned surgery. The main goal was to measure changes in a tumor growth marker called Ki-67, gathering data to help design larger future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
omega-3 fatty acid (fish oil) and celecoxib
What this could lead to
If successful, this could point toward a way to reduce inflammation in pregnancy-associated breast cancer, potentially improving treatment options for this aggressive form of the disease.
What could go wrong
This is a very early, small study (42 participants) designed mainly to gather preliminary data, not to prove effectiveness. The results may not lead to a direct treatment, and the drugs may not show a meaningful effect on cancer growth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

42 people

The number who actually took part.

Started

Dec 2009

Finished

Dec 2015

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 to 50 years

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: * Age greater or equal to 18 and less than or equal to 50. * Histological or cytological confirmation of breast cancer; for patients with fine needle aspiration (FNA), a core biopsy must be intended * For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides must be available or patient must be willing to undergo repeat core biopsy for research purposes as part of study procedures (biopsy for fresh/ fresh frozen tissue is otherwise optional) * Any clinical stage allowed provided definitive local resection intended and neoadjuvant treatment not intended * Patient must be planned to proceed to definitive surgery for their breast cancer at least 1 week or more after diagnosis * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patient must have laboratory parameters as follows: * Liver function tests (Total bilirubin, aspartate aminotransferase, alanine aminotrasferase, alkaline phasphataseAST) =\< 2 x ULN * Platelet count greater than or equal to institutional lower limit of normal (LLN) * Patient cannot have greater than grade 1 anemia as determined by hematocrit (Hct) * Written informed consent obtained prior to any initiation of study procedures * Willingness to abstain from either fish oil or celebrex for study period if randomized to control arm * Women who are lactating at time of diagnosis are eligible provided they complete weaning prior to starting study drug Exclusion Criteria: * Known autoimmune condition, chronic steroid use, underlying immune disease (other than breast cancer), use of immunomodulatory prescription drugs for any medical condition * Known allergy or intolerance to fish oil, fish, non-steroidal anti-inflammatory drugs (NSAIDS), acetylsalicylic acid (ASA) or cyclooxygenase-2 (COX 2) inhibitors * Known bleeding diathesis or history of peptic ulcer disease; gastroesophageal reflux allowed if controlled * Currently taking greater than one 1000mg fish oil capsule daily or celecoxib at baseline, unless willing to stop consumption 1 week prior to starting study * History of stroke, transient ischemic attack (TIA) or coronary artery disease * The presence of other comorbid conditions known to impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe chronic obstructive pulmonary disease (COPD), uncontrolled infection or known human immunodeficiency virus \[HIV\] infection) * Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements * Women who are pregnant at time of breast cancer diagnosis and intend to continue the pregnancy; if pregnancy is terminated per patient's cancer decision making, they would be eligible for participation afterwards * History of other malignancy besides current diagnosis of breast cancer, unless definitively treated more than 5 years ago * Any history of Hodgkin's disease requiring mantle field irradiation * Any previous diagnosis of breast cancer

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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 Colorado Cancer Center

    Aurora, Colorado, 80045, United States

More trials for these conditions

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