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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 583
- 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
- 未提供
排除标准
- 未提供
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 (583)
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