Randomized Phase III Trial Comparing Conventional Vitamin D Supplementation vs. Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients Treated by Neoadjuvant or Adjuvant Chemotherapy.
概览
- 阶段
- 3 期
- 干预措施
- calcium and cholecalciferol
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Institut du Cancer de Montpellier - Val d'Aurelle
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- To evaluate the increase in normalization of serum vitamin D level
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The purpose of this study is to compare normalization of vitamin D serum level after 6 months of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional vitamin D supplementation.
研究者
入排标准
入选标准
- •Breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 months prior to study enrollment
- •WHO performance status 0-1
- •Age ≥18 years old
- •Affiliation to a social security regime or beneficiary of equivalent social protection
- •Written informed consent provided before any study specific procedures
- •Complementary inclusion criterion for randomization
- •\- Proved vitamin D deficiency as defined by serum vitamin D level lower than 30 ng/ml (75 nmol/L).
排除标准
- •Metastatic disease
- •History or presence of any other malignancy (except curatively treated nonmelanoma skin cancer or in situ cervix carcinoma) ………….
- •traités dans les 5 ans précédents.
- •Contraindication to calcium or cholecalciferol
- •Known severe hypersensitivity to vitamin D or to calcium supplementation or to one of the excipients.
- •Disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria
- •Calcium lithiasis and tissue calcification
- •Hypervitaminosis D
- •Presence of significant comorbidities:
- •i) Uncontrolled endocrine disease ii) Known disorders of calcium phophorus laboratory testing iii) Proved osteopenia or osteoporosis requiring vitamin D and calcium supplements
研究组 & 干预措施
Conventional vitamin D and calcium supplementation
Conventional vitamin D and calcium supplementation with 2 daily OROCAL VITAMINE D3® (500 mg calcium/200 IU cholecalciferol) tablets.
干预措施: calcium and cholecalciferol
vitamin D supplementation tailored to vitamin D deficiency
Conventional calcium supplementation with 2 daily OROCAL 500® (500 mg calcium) tablets to suck + vitamin D3 supplementation (UVÉDOSE®, cholecalciferol, 100 000 IU drinkable solution, 2 ml vial) whose schedule of administration depends on vitamin deficiency level: * 100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25OHD level \< 10 ng/mL * 100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25OHD level \< 20 ng/mL * 100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25OHD level \< 30 ng/mL
干预措施: calcium and cholecalciferol
结局指标
主要结局
To evaluate the increase in normalization of serum vitamin D level
时间窗: 6 months
To compare the increase in normalization of serum vitamin D level adjusted to baseline level in patients receiving either vitamin D supplementation tailored to vitamin D deficiency or conventional vitamin D supplementation.
次要结局
- Predictive value of individual biomarkers(Up to 24 months)
- Baseline vitamin D/calcium status in this patient population(Baseline)
- Normalization rate of serum 25-OHD level(12, 18 and 24 months)
- Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy(6 months after crossover)
- Clinical and biological tolerance profile(During treament administration (can last up to 24 months))
- Changes in vitamin and calcium biological markers(Up to 24 months)
- Treatment compliance(During treatment administration (can last up to 24 months))
- Quality of life(24 months)
- Impact of study treatments on bone and joint pains induced by aromatase inhibitors(During treatment administration (can last up to 24 months))