A PHASE II Multicentric Trial Evaluating a High Dose Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer Treated by Adjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Normalisation of Vitamin D level
研究概览
简要总结
An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy.
A calcium supplementation will be prescribed in parallel.
An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Breast adenocarcinoma should receive 6 cycles of adjuvant chemotherapy
- •Women ≥ 18 years old (no age limit)
- •Performance status :0 or 1
- •Patients must be affiliated to a Social Security System
- •Signed informed consent obtained before any study specific procedures.
- •Vitamin D deficiency confirmed ( vitamin D result must be < at 30 ng/ml)
排除标准
- •Metastatic disease
- •Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years
- •calcium or colecalciferol contraindications (vitamin D hypersensitivity - disease or an other condition result in hypercalcaemia or hypercalciuria -Calcic lithiasis- high vitamin D level)
- •Presence of the following diseases in the last 3 years : endocrinal disease, A phosphor calcic disorder treated by vitamin D supplementation at 1000 UI/day or more (this patient who have received a dose < 1000 UI/day, will be included after have to stop Vitamin D at least 48 hours ) - Osteopenia or osteoporosis confirmed treated
- •Concomittant treatment with an other experimental product
- •Pregnant or breastfeeding women
- •Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
研究组 & 干预措施
VITAMIN D SUPPLEMENTATION ARM
On day 1 of every chemotherapy cycle, the patient will be receive an oral solution of vitamin D (UVEDOSE/calciferol).
In parallel,a calcium supplementation is prescribed.
干预措施: VITAMIN D (Dietary Supplement)
结局指标
主要结局
Normalisation of Vitamin D level
时间窗: from the Cycle 1 to cycle 6 (each cycle is 21 days)
percentage of vitamin D level normalisation
次要结局
- initial vitamin D and calcium level(at cycle 1( one cycle is 21 days))
- vitamin D and calcium level(from cycle 1 to 24 months (one cycle is 21 days))
- normalization of 25-OHD (vitamin D)(at FU 6,12,18,24 months after the first dose of vitamin D)
- adverses events rates(from cycle 1 to follow-up 24 months (one cycle is 21 days))