A Randomized, Controlled Trial of High Dose vs. Standard Dose Vitamin D for Aromatase-Inhibitor Induced Arthralgia in Breast Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy
研究概览
简要总结
This study is being done to look at the difference, if there is a difference between two different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients. The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent aromatase inhibitor arthralgia (AIA).
详细描述
Treatments with anti-estrogen agents for hormone receptor positive breast cancer is the most efficacious of systemic therapies, with aromatase inhibitors (AI's) being considered the most active anti-estrogen therapy in early stage breast cancer. But, use of these treatments has been shown to cause musculoskeletal (joint/muscle) side effects that sometimes cause patients to discontinue the use of them. Also, Vitamin D deficiency is a well know cause of a wide array of musculoskeletal issues. There is evidence that Vitamin D supplementation may help prevent arthralgia while on AI's. Therefore, the investigators want to see if giving a higher dose of Vitamin D could decrease the incidence of AIA as compared to a standard dose of Vitamin D. The investigators believe that this could possibly result in patients continued treatment with AI therapy for hormone receptor positive breast cancer.
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
- 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
- •All participants must be female and at least 21 years of age
- •Signed informed consent
- •Patients must have had histologically confirmed stage I-III breast carcinoma that is positive for Estrogen Receptor (ER) and/or Progesterone Receptor (PR).
- •Post-menopausal
- •Beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6 weeks
- •Bisphosphonates are allowed at the treating investigator¡¦s discretion
- •Performance status (WHO/ECOG scale) 0-2.
排除标准
- •History of kidney stones
- •Hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory's normal parameters
- •History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator's discretion
- •Baseline Vitamin D level greater than 50 ng/mL
- •Inability or unwillingness to comply with, or follow study procedures.
- •Currently taking Phenytoin or phenobarbital -7 Currently taking cholestyramine or orlistat
- •Malabsorption syndrome, such as Crohn's disease
- •Prohibited Therapies: Patients may not take additional Calcium and Vitamin D aside from the study medications. Patients who are on cholestyramine or orlistat will not be allowed on the trial. Also, patients who are taking phenytoin or phenobarbital are not allowed on the trial either because of interaction between Vitamin D and anti-epileptic medications.
研究组 & 干预措施
High Dose Vitamin D ARM
50,000 IU Vitamin D supplement
干预措施: 50,000 IU Vitamin D supplement (Drug)
800 IU Vitamin D Supplement
800 IU Vitamin D Supplement
干预措施: 800 IU Vitamin D Supplement (Drug)
结局指标
主要结局
Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy
时间窗: 12 weeks
Aromatase Inhibitor Arthralgia (AIA) was assessed by a questionnaire that describe the level of pain experienced by the participant. The questionnaire asks 20 questions scored 0-3 in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. An average composite score on the HAQ-II was calculated. The visual analog scale is the other major component of the HAQ-II, which we ask patients to mark where their pain lies on a horizontal line and we converts the number into a score from 0 to 3. For the purposes of this study, AIA will be defined as any of the following criteria: 1) increase in HAQ-II score from baseline by 0.2 or greater; or 2) increase in visual analog pain score by 0.3 or greater.
次要结局
- Association Between Vitamin D Levels Changes and Treatment.(12 weeks)
- Compliance With Anti-Cancer Treatment(52 Weeks)
研究者
Mothaffar Rimawi
Professor
Baylor Breast Care Center