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Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study

18 Years
Open (Enrolling)
Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

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Trial Information

Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study


I. To assess the feasibility of evaluating joint symptoms in postmenopausal women with
breast cancer randomized to n-3 PUFA (omega-3 fatty acid) vs. placebo supplementation using
the Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine subscale
(FACT-ES), Brief Pain Inventory (BPI) and Stanford's Health Assessment -Disability Index
(HAS) during the first 6 months of adjuvant aromatase inhibitor (AI) therapy.

II. To preliminarily evaluate the efficacy of n-3 PUFA vs. placebo supplementation on AI
induced joint symptoms.

III. To explore blood and imaging based biomarkers (plasma and red blood cell [RBC] levels
of n-3 PUFAs, inflammatory cytokines and receptors, and intra-articular tenosynovial
inflammation by musculoskeletal magnetic resonance imaging [MRI] imaging) of AI-induced
joint symptoms in women on AI therapy randomized to n-3 PUFAs vs. placebo supplementation.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive omega-3 fatty acid orally (PO) once daily (QD) for 6 months in the
absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD for 6 months in the absence of disease progression or
unacceptable toxicity.

Inclusion Criteria:

- Women diagnosed with breast cancer stages I-III initiating first adjuvant AI therapy
with any of the Food and Drug Administration- (FDA) approved AIs (anastrozole,
exemestane, letrozole)

- Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed

- Concurrent breast related radiation therapy is allowed

- Prior tamoxifen use is allowed

- Prior chemotherapy is allowed

- History of osteoarthritis and/or fibromyalgia is allowed

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Metastatic malignancy of any kind

- Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease,
with the exception of osteoarthritis and fibromyalgia

- AI use > 2 weeks prior to study enrollment

- Known bleeding disorders

- History of diabetes mellitus, heart disease or TIA/stroke

- Current use of warfarin or other anticoagulants

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia,or psychiatric illness/social situation that would limit compliance with
study requirements

- Daily use of n-3 PUFA concentrates or capsules or regular or any other supplements
that might interact with n-3 PUFA supplements within six months of study initiation;
sporadic use of n-3 PUFA supplement may be eligible if there has been a 3-month
washout period prior to randomization

- Pregnant or nursing women

- Known sensitivity or allergy to fish or fish oil

- Concurrent use of daily full dose aspirin (≥ 325 mg/day), nonsteroidal
anti-inflammatory drugs (NSAIDs) or NSAID-containing products or steroids; one month
washout period is required prior to randomization

- Unable to give informed consent

- In patients consenting for optional MRIs, any contraindication to MRI examination
including but not limited to ferromagnetic metal in the body, pacemaker, or severe

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument

Outcome Description:

Pain scores based on FACT-B/ES, HAS and BPI will be plotted over time for each arm. Agreement between HAS, BPI-short and FACT-B/ES evaluated using Altman and Bland plot after proper data transformation. Also, Linear Mixed model used to explore if the pain scores are different at 3 and 6 months. Logistic regression models used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups, with potential covariates including age, body mass index, baseline pain scores (0 month), prior chemotherapy and other variables.

Outcome Time Frame:

baseline, 6 months

Safety Issue:


Principal Investigator

Maryam Lustberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

October 2011

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Breast Cancer
  • Breast Neoplasms



Ohio State University Medical CenterColumbus, Ohio  43210