Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from baseline in musculoskeletal pain and 250HD levels
研究概览
简要总结
The third generation oral aromatase inhibitors (AIs) are increasingly being used in the management of estrogen receptor positive breast cancer. One of the issues related with administration of oral AIs is their side effects, particularly on the musculoskeletal system. Although the prevalence and importance of arthralgia and myalgia occurring in BC patients receiving adjuvant AIs are evident, the mechanisms clearly explaining these invalidating symptoms are unknown.
In this project, we aim to unravel the interaction between vitamin D and musculoskeletal adverse events experienced by AI users. We will also evaluate how vitamin D supplementation affects AI-induced musculoskeletal symptoms in breast cancer patients, by means of a randomized placebo-controlled double blind clinical trial. We will assess changes in the musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and also monitor serum IGF-I and estrogen levels together with bone resorption and formation markers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 status
- •Currently being treated with an AI in the adjuvant setting (minimum for 8 weeks)
- •AIMSS as determined by new or worsened musculoskeletal complaints following AI therapy
- •Vitamin D deficiency (<30ng/ml)
- •Caucasian
排除标准
- •Hormone replacement therapy last 6 months
- •Current use or in the last 12 months of bisphosphonates
- •Tamoxifen use in last 6 months
- •History of kidney stones
- •History of hypercalcemia/hypercalciuria or hyperthyroidism
- •Paget's disease of the bone
- •Current use of Digitalis/digoxin or thiazide diuretics
- •Current use of vitamin D (or multivitamin) supplementation should be stopped
研究组 & 干预措施
vitamin D3
1000 mg Ca2+/800IU vitamin D3 daily + 25 000IU vitamin D3 weekly during 6 months
干预措施: Vitamin D3 (Drug)
Placebo
1000 mg Ca2+/ 800IU vitamin D3 daily + 25000IU placebo every week during 6 months
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in musculoskeletal pain and 250HD levels
时间窗: 3 monthly during one year
次要结局
- Change from baseline in bone parameters, estrogen and IGF-I levels and fluid accumulation and tendon pathologies, as seen on MRI(3 monthly during 1 year, MRI at baseline and 3 months)