S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy
Condition: Arthralgia; Breast Cancer; Pain
MeSH terms: Breast Neoplasms; Arthralgia
Intervention: omega-3 fatty acid; placebo
Intervention description: Given orally; Given orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 262.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; pain; arthralgia

Summary:

      RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and
      bone pain and stiffness caused by hormone therapy in patients with breast cancer.

      PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in
      treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III
      breast cancer receiving hormone therapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary invasive adenocarcinoma of the breast

               -  Stage I, II, or IIIA disease

               -  No metastatic disease

          -  Must have undergone modified radical mastectomy or breast-sparing surgery and
             recovered

          -  Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+)

          -  Currently taking a third-generation aromatase inhibitor (AI) [e.g., anastrozole
             (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)] for ≥ 90 days prior to
             registration with plans to continue for ≥ 180 days after registration

          -  Must have completed the S092 Brief Pain Inventory (BPI)-Short Form within the past 14
             days, and must have a worst pain/stiffness of ≥ 5 on the BPI (item #2) that has
             started or increased with AI therapy

        PATIENT CHARACTERISTICS:

          -  Postmenopausal

          -  Zubrod performance status 0-2

          -  Willing to submit blood for serum-free estradiol, total estradiol, serum inflammatory
             markers (IL6, TNF-α, CRP), DHA and EPA, lipid profile (LDL, HDL, triglycerides), and
             DNA analysis (CYP19A1)

          -  Able to complete study questionnaires in English

          -  At least 5 years since other malignancy except adequately treated basal cell or
             squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the
             breast or adequately treated stage I or II cancer from which the patient is currently
             in complete remission

          -  Patients must not have a known allergy to soy, given that the placebo is suspended in
             soybean oil

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 3 months since prior omega-3 fatty acid supplements and must agree to refrain
             from omega-3-fatty acid supplements from sources outside of this study

          -  More than 28 days since prior investigational agents

          -  No other medical therapy, alternative therapy, or physical therapy for joint
             pain/stiffness within the past 30 days

          -  Patients must not be on anticoagulation medication (i.e., heparin/warfarin) because of
             increased risk of bleeding within 28 days prior to registration

          -  Patients must not have a history of bone fracture or surgery of the afflicted knees
             and/or hands within 6 months prior to registration

          -  Patients must not be on narcotics within 14 days of registration

          -  Patients may have received corticosteroid treatment; however, the following criteria
             apply:

               -  Patients must not have received oral or intramuscular corticosteroids within the
                  28 days prior to registration

               -  Patients must not have received intra-articular steroids to the study, or any
                  other, joint within 28 days prior to registration

          -  Patients must not have received topical analgesics (e.g., capsaicin preparations) to
             the study joint or any other analgesics (e.g., opiates, tramadol; with the exception
             of nonsteroidal antiinflammatory drugs (NSAIDs) and acetaminophen) within 14 days
             prior to registration