A Randomized, Open-label Study of High-Dose Vitamin D Versus Standard of Care Vitamin D Supplementation to Evaluate the Impact on Bone Health in Young Women With Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan
研究概览
简要总结
This is a randomized study evaluating the effects of early intensive vitamin D supplementation compared to standard of care vitamin D supplementation on bone health over an 18 month period.
详细描述
This is a randomized, open-label study designed to evaluate the effect of high dose vitamin D versus standard of care vitamin D supplementation on bone health and arthralgias. The randomization will be stratified by hormone receptor status (positive versus negative). The primary objective is to compare the effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on bone health, as measured by percent change from baseline in bone mineral density (g/cm2), in young women with non-metastatic breast cancer who receive systemic therapy.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject must meet all of the following applicable inclusion criteria to participate in this study:
- •Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- •Age; 45 years at the time of consent
- •Histological or cytological confirmation of breast cancer clinical or pathologic stages 0-III
- •Patient has been recommended to initiate systemic therapy for breast cancer. It is preferable for patient to enroll prior to systemic therapy initiation. However, enrollment will be allowed if systemic therapy has been initiated within 4 weeks prior to enrollment (randomization).
- •Note: Patients who undergo only surgery and/or radiotherapy alone would not qualify for the study.
- •Systemic therapy for breast cancer is planned
- •As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study
- •Previous vitamin D supplementation allowed, as long as patient is agreeable to stop previous dosing at the time of trial enrollment, to comply with trial procedures including a baseline 25(OH)D level, and is otherwise determined to be appropriate for enrollment
排除标准
- •Subjects meeting any of the criteria below may not participate in the study:
- •1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the Investigator
- •2. Patients will undergo breast surgery and/or radiotherapy alone without planned neoadjuvant and/or adjuvant anti-cancer drug therapy.
- •3. Baseline 25(OH)D level \<10ng/mL or \>80ng/mL
- •4. Baseline serum corrected calcium level of \>10.3mg/dL
- •5. Bone mineral density less than the expected range for age on baseline DEXA scan (defined as Z-score \/=12 months and/or ovarian function laboratories (estradiol, FSH) consistent with menopause (if any of two values outside of menopausal range and subject had menses within 12 months, subject would be considered perimenopausal or premenopausal and therefore eligible for enrollment)
- •9. Pregnancy or lactation
- •10. History of bone disease, including Paget's bone disease or osteomalacia
- •11. Concurrent rheumatoid or other inflammatory arthritis
- •12. Concurrent or prior treatment with bisphosphonates
- •13. Use of oral corticosteroids within the last 30 days prior to randomization
- •14. Concurrent treatment for thyroid deficiency
- •15. BMI \<18.5
- •16. Currently receiving treatment for tuberculosis, or planning to receive treatment for tuberculosis during breast cancer treatments
- •17. History of another primary cancer that required systemic treatment within the last 5 years
- •18. Any of the following kidney diseases at the time of randomization: active chronic kidney disease \>/= stage 3, history of kidney stones, sarcoidosis
- •19. Gastrointestinal disease that would limit the absorption of pill therapy (i.e. celiac disease, gastric bypass surgery)
研究组 & 干预措施
High Vit D
High Dose Vitamin D
干预措施: High Dose Vitamin D (Dietary Supplement)
SOC Vit D
Standard of Care Vitamin D
干预措施: Standard of Care Vitamin D (Dietary Supplement)
结局指标
主要结局
Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan
时间窗: 15 months (12 plus a +3 month calendar window)
Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on bone health, as measured by percent change from baseline in bone mineral density (g/cm2) to the Year 1 planned DEXA scan, in young women with non-metastatic breast cancer who receive systemic therapy.
次要结局
- PRAI questionnaire results over time(18 months)
- Skeletal complications over time(18 months)
- 25(OH) D level over time(18 months)
- Overall satisfaction with pain control over time(18 months)