Phase 3
Completed N=262
S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy
Arthralgia · Breast Cancer · Postoperative Pain
Source: ClinicalTrials.gov NCT01385137 ↗
Enrolled (actual)
262
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score — 5.3; 5.47 BPI score — p=0.58
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score |
5.3; 5.47 | 0.58 |
| SECONDARY Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug |
0; 1; 1; 0; 1; 0 | — |
| SECONDARY Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score |
34.5; 36.7 | 0.42 |
| SECONDARY Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score |
28.8; 28.1 | 0.77 |
| SECONDARY Week 12 Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Score |
95; 92.8 | 0.21 |
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
Data sourced from ClinicalTrials.gov (NCT01385137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.