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Randomized Phase II Study of Omega-3-Fatty Acid on Joint Symptoms Induced by Aromatase Inhibitors in Breast Cancer Patients

Phase 2
21 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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 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.

Inclusion Criteria:

- 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.

- 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

Exclusion Criteria:

- 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

- 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:

1. Use of oral corticosteroids within the previous four weeks.

2. Exposure to intramuscular corticosteroids within one month prior to entering the

3. Administration of intra-articular steroids to the study joint, within 3 months
of Randomization Visit.

4. 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

A change in serum free and total estradiol levels.

Outcome Time Frame:

At week 3

Safety Issue:


Principal Investigator

Dawn Hershman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

June 2009

Completion Date:

May 2011

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Columbia University Medical Center New York, New York  10032