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


N/A
18 Years
N/A
Open (Enrolling)
Female
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


OBJECTIVES:

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
claustrophobia

Type of Study:

Interventional

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:

No

Principal Investigator

Maryam Lustberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-11022

NCT ID:

NCT01478477

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

Name

Location

Ohio State University Medical Center Columbus, Ohio  43210