A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 712
- 主要终点
- Average Joint Pain According to BPI-SF
研究概览
简要总结
RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.
PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.
详细描述
OBJECTIVES:
Primary
- To assess whether daily duloxetine hydrochloride (duloxetine) decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal syndrome (AIMSS), as measured at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF).
Secondary
- To assess whether daily duloxetine decreases worst joint pain in women with AIMSS, as measured at 12 weeks by the modified BPI-SF.
- To assess whether daily duloxetine decreases pain interference in women with AIMSS, as measured at 12 weeks by the modified BPI-SF.
- To investigate whether daily duloxetine improves functioning, pain, and stiffness in the knees/hips according to the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale. (Exploratory)
- To investigate whether daily duloxetine improves function, pain, and stiffness in the hands according to the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH). (Exploratory)
- To investigate whether daily duloxetine improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES). (Exploratory)
- To investigate whether daily duloxetine improves the proportion of patients reporting changes for the better versus worst as measured by the Global Rating of Change Scale. (Exploratory)
- To investigate whether daily duloxetine decreases analgesic use.
- To investigate whether daily duloxetine increases adherence to, and reduces the discontinuation rate for, aromatase inhibitor (AI) therapy. (Exploratory)
- To assess whether patients receiving duloxetine as compared to placebo have improved depression as measured by the Patient Health Questionnaire (PHQ-9) at Weeks 6 and 12. (Exploratory)
- To explore the relationship between inherited variants in genes responsible for duloxetine metabolism and activity (COMT, HTR3A, SLC6A2, SLC6A4, CYP1A2, CYP2D6) and aromatase (CYP19A1) and change in pain with 12 weeks of treatment. (Exploratory)
- To explore the impact of treatment on serum inflammatory cytokine levels with 12 weeks of treatment at baseline and 12 weeks. (Exploratory)
- To bank blood samples for future correlative analyses. (Exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 120 Years（Child, 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
研究组 & 干预措施
Arm I
Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.
干预措施: duloxetine hydrochloride (Drug)
Arm II
Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.
干预措施: placebo (Other)
结局指标
主要结局
Average Joint Pain According to BPI-SF
时间窗: Weeks 2, 6, 12, and 24; Week 12 reported
Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".
次要结局
- Pain Interference According to the BPI-SF(Weeks 2, 6, 12, and 24; Week 12 reported)
- Worst Joint Pain According to the BPI-SF(Weeks 2, 6, 12, and 24; Week 12 reported)