NCT04754399已完成2 期
Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15
研究概览
简要总结
Study of Cannabidol to examine the safety and efficacy of 15 weeks of CBD in postmenopausal women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Investigators are looking to see if patients with joint pain see improvement with the use of CBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal according to standard clinical criteria OR receiving concomitant LHRH agonist therapy.
- •Taking aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment.
- •Planning to take the same AI therapy for at least 15 weeks.
- •New or worsening joint pain and/or myalgias since starting the AI therapy.
- •Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months prior to enrollment.
- •The complete list of inclusion criteria is provided in the protocol.
排除标准
- •Metastatic breast cancer.
- •Planned surgery during the 15-week study period.
- •Clinically significant laboratory abnormalities.
- •Use of cannabidiol, THC, or marijuana (oral, inhaled, or topical) within the 6 weeks prior to enrollment.
- •History of or currently has suicidal ideation or attempted suicide.
- •History of seizure other than febrile seizures in childhood.
- •The complete list of exclusion criteria is provided in the protocol.
研究组 & 干预措施
Cannabidiol (CBD)
Experimental
Oral solution given 2x daily.
干预措施: Cannabidiol (CBD) (Drug)
结局指标
主要结局
Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15
时间窗: Baseline, week 15
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, absolute change for only one BPI item will be assessed, "joint pain and stiffness at its worst in the last week".
次要结局
- Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15(Baseline, week 15)
- Number of Patients With at Least a 2-point Reduction in BPI Average Pain From Baseline to Week 15(Baseline, week 15)
- Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1(Baseline, week 15)
- Number of Treatment Related Adverse Events(End of study (15 weeks))
- Number of Participants With Undetectable Levels of Estradiol(Baseline and week 15)
研究者
研究点 (1)
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