NCT01385137已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 292
- 主要终点
- Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score
研究概览
简要总结
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.
详细描述
OBJECTIVES:
Primary
- To assess whether omega-3-fatty acid as compared to placebo causes a reduction in worst joint pain and/or stiffness at 12 weeks, as measured by the modified Brief Pain Inventory (BPI), in women with early-stage breast cancer and aromatase inhibitor (AI)-associated arthralgia.
Secondary
- To assess the proportion of patients who report improved versus deteriorated joint pain with omega-3-fatty acid versus placebo.
- To assess the proportion of patients who report improved versus deteriorated joint stiffness with omega-3-fatty acid versus placebo.
- To assess whether patients receiving omega-3-fatty acid compared to placebo have decreased analgesic use and increased AI adherence.
- To assess whether patients receiving omega-3-fatty acid compared to placebo have improved functioning, pain, and stiffness in the knees/hips (as measured by the Western Ontario and McMaster Universities Osteoarthritis, WOMAC) score.
- To assess whether patients receiving omega-3-fatty acid have improved functioning, pain, and stiffness in the hands (as measured by the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, M-SACRAH).
- To assess whether patients receiving omega-3-fatty acid compared to placebo have improved functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Trial Outcome Index (TOI).
- To assess whether patients receiving omega-3-fatty acid report changes for the better versus worse compared to placebo as measured by the Global Rating of Change Scale.
- To identify minimally important change in the WOMAC, M-SACRAH, and the FACT-ES Trial Outcome Index (TOI) using "a little better" or "a little worse" responses on the patient-reported global rating of change in joint pain and joint stiffness.
- To assess whether patients receiving omega-3-fatty acid compared to placebo have an improved lipid profile as measured by triglycerides, HDL, and LDL.
- To assess the toxicity of omega-3-fatty acid compared to placebo in this setting.
- To assess whether there is a difference in serum-free and total estradiol levels before and after treatment with omega-3-fatty acid compared to placebo.
- To explore whether CYP19A1 genotype correlates with severity of joint symptoms or predicts response to omega-3-fatty acid. (exploratory)
- To explore changes in hormonal and inflammatory serum biomarkers, such as IL6, TNF-α, and CRP.
- To assess whether there is a relationship between change in serum docosahexaenoic acid (DHA) and EPA and resolution of joint symptoms.
- To establish a cohort of patients (placebo group) to better characterize the natural history of the syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm II
Placebo Comparator
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Other)
Arm I
Experimental
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: omega-3 fatty acid (Dietary Supplement)
结局指标
主要结局
Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score
时间窗: 12 weeks post-registration
Linear regression model-adjusted week 12 mean score by treatment group. Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10
次要结局
- Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug(Up to 25 weeks)
- Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score(12 weeks post-registration)
- Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score(12 weeks post-registration)
- Week 12 Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Score(12 weeks post-registration)
研究者
研究点 (292)
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