Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change in Hand Grip Strength
研究概览
简要总结
The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.
详细描述
This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Women with a history of stage I-IIIa invasive breast cancer
- •History of hormone-receptor positive cancer (either ER + or PR + or both)
- •Are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of AI treatment remaining
- •Are experiencing AIMSS
排除标准
- •Unable to read or understand English
- •History of psychiatric disability affecting informed consent or compliance with drug intake
- •Malabsorption syndrome or inability to take oral medication
- •Has less than 7 months of AI therapy remaining
研究组 & 干预措施
Vitamin D3 4000 IU
干预措施: Vitamin D3 (Drug)
Vitamin D3 600 IU
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Change in Hand Grip Strength
时间窗: baseline to 6 months
Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale
时间窗: baseline to 6 months
The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia
次要结局
- Average Percent Adherence to Vitamin D Interventio(average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months)
- Serum Estradiol Concentrations(baseline and 6 months)
- Vitamin D Binding Protein Genotype(Baseline)
- Change in PROMIS Physical Functioning Questionnaire(baseline to 6 months)
- Whole Body Bone Mineral Density(From Baseline and 6 months of D3 supplementation)
- Change in Steady State Concentrations of Serum Anastrazole and Letrozole(baseline to 6 months)