Please select the eligibility criteria that correspond to the clinical trial below.
Title: S0927: A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness In Women With Early Stage Breast Cancer, Phase III
Brief 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.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed resectable adenocarcinoma of the breast

  * pT1, pT2, pT3, or minimal dermal involvement on pathology only
  * pN0, pN1, pN2, or M0

    * Negative nodal status

      * At least 8 nodes are negative
    * Unknown nodal status

      * Less than 8 nodes examined and no pathological finding
    * Positive nodal status

      * Any positive finding independent of the number of nodes examined
  * Negative sentinel node or no prior nodal dissection allowed if all other criteria met
* Must have had total mastectomy, lumpectomy, or quadrantectomy

  * Should have prior chest wall radiotherapy after segmental mastectomy or histopathologic T4 dermal involvement
* Stage I, II, or IIIa allowed if the tumor is completely removed macroscopically and margins of the resected tumor are microscopically free of tumor
* Must undergo chest wall radiotherapy or second resection if microscopic disease at the mastectomy margins
* No bilateral disease except in situ disease, either ductal or lobular of the contralateral breast
* Postmenopausal

  * Regardless of prior hormonal replacement therapy (HRT) or hysterectomy:

    * Bilateral oophorectomy and any age
    * Radiologic castration and amenorrheic for at least 3 months and any age
    * Not postmenopausal at the start of adjuvant chemotherapy AND and completed at least 6 courses of prior cyclophosphamide, methotrexate, and fluorouracil (CMF) or at least 4 courses of prior anthracycline-cyclophosphamide continuation therapy and at least age 45 with follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) postmenopausal levels
  * No prior HRT:

    * Prior hysterectomy and less than age 55 with FSH/LH/E2 postmenopausal levels
    * Prior hysterectomy and at least age 55
  * No prior HRT or hysterectomy:

    * Amenorrhea more than 1 year and less than age 50
    * Amenorrhea more than 6 months and at least age 50
  * Prior HRT regardless of hysterectomy:

    * At least 1 month since prior HRT and less than age 55 with FSH/LH/E2 postmenopausal levels
    * At least 1 month since prior HRT and at least age 55
  * FSH/LH/E2 postmenopausal levels and uncategorized
* No distant metastases, including bone scans showing hot spots unconfirmed as benign disease or skeletal pain of unknown cause
* At least 10% hormone receptor-positive tumor cells
* Hormone receptor status:

  * Estrogen receptor positive AND/OR
  * Progesterone receptor positive

PATIENT CHARACTERISTICS:

Age:

* 30 and over

Sex:

* Female

Menopausal status:

* Postmenopausal

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10 g/dL

Hepatic:

* Bilirubin less than 3.0 mg/dL
* SGOT or SGPT less than 1.5 times upper limit of normal
* No hepatic disease that would preclude study

Renal:

* Creatinine less than 1.8 mg/dL
* No renal disease that would preclude study

Cardiovascular:

* No cardiovascular disease that would preclude study
* Prior deep vein thrombosis allowed if medically stable

Pulmonary:

* No lung embolism

Other:

* No other prior or concurrent malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No prior noncompliance to medical regimens
* No other nonmalignant systemic diseases that would preclude follow-up
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior immunotherapy or biological response modifiers (e.g., interferon) allowed

Chemotherapy:

* See Disease Characteristics
* Prior adjuvant or neoadjuvant chemotherapy allowed
* Concurrent adjuvant chemotherapy allowed

Endocrine therapy:

* See Disease Characteristics
* Prior neoadjuvant hormonal therapy allowed (e.g., antiestrogens, progestins, or aromatase inhibitors) if no more than 4 months duration and no disease progression
* Prior corticosteroids allowed
* At least 4 weeks since prior HRT
* Prior adjuvant antiestrogen therapy allowed if less than 1 month duration and immediately after surgery, radiotherapy, and/or chemotherapy
* Prior antiestrogens for chemoprevention allowed if at least 18 months between completion of chemoprevention and diagnosis
* No other concurrent antiestrogens or aromatase inhibitors
* No concurrent raloxifene
* No concurrent systemic HRT with or without progestins of more than 3 months duration

Radiotherapy:

* See Disease Characteristics
* Concurrent radiotherapy allowed

Surgery:

* See Disease Characteristics

Other:

* At least 30 days since prior systemic investigational drugs
* At least 7 days since prior topical investigational drugs
* Concurrent bisphosphonates allowed
B: Inclusion Criteria:

* Age ≥ 18 years
* Women with a history of stage I-IIIa invasive breast cancer
* History of hormone-receptor positive cancer (either ER + or PR + or both)
* Are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of AI treatment remaining
* Are experiencing AIMSS

Exclusion Criteria:

* Unable to read or understand English
* History of psychiatric disability affecting informed consent or compliance with drug intake
* Malabsorption syndrome or inability to take oral medication
* Has less than 7 months of AI therapy remaining
C: 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
D: Inclusion Criteria:

* Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses \>1 year ago or Serum FSH (\> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy
* Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
* Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months
* In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.

Exclusion Criteria:

* Patients with severe renal function disorders (Creatinine clearance \< 20 ml/min or Patients with moderate or severe disorders of hepatic function
* Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
* Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
* Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program

Answer: C