Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 4
- 主要终点
- Relapse Free Survival
研究概览
简要总结
To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.
详细描述
To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years and younger than 80 years of age.
- •Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial.
- •The only treatment for melanoma is surgical treatment.
- •Complete resection of melanoma.
- •Single primary invasive cutaneous melanoma
- •Signed ethical committee approved informed consent
- •Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference
- •Exclusion criteria
- •Pregnant/lactating women or planning on becoming pregnant during the study
- •Known hypersensitivity to vitamin D or its components.
- •Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or renal dialysis.
- •Liver failure or chronic liver disease with liver enzymes > 2 fold upper limit of normal (ULN).
- •History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
- •History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
- •History of small intestine resection.
- •History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma.
- •Chronic alcohol abuse.
- •Medical or logistic problems likely to preclude completion of the study.
- •Taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists)
- •Intake of vitamin D supplements within 6 months prior to entry of the study.
排除标准
- 未提供
研究组 & 干预措施
Vitamin D
Every month 100 000 units of Vitamin D in syringe oral dispenser is taken . Study duration is maximum 3,5 years or until relapse occurs
干预措施: Vitamin D (Drug)
结局指标
主要结局
Relapse Free Survival
时间窗: study duration maximum 9 years and 7 months or until relapse
Disease free survival will be the primary endpoint of this phase III trial. Study duration for one patient is maximum 9 years and 7 months. Patients are supplemented with studymedication (Vitamin D or placebo) for maximum 3.5 years. This is the treatment period. After the treatment period (in which the patients take study medication, placebo or Vitamin D), there is the follow-up period, no more study medication is taken, the study is still double blind, and the patients are followed at the clinical department for relapse and/or death.
次要结局
- Melanoma Subtype, as Assessed Clinically and Histologically(Time at diagnosis)
- Melanoma Site, as Clinically Recorded(Time at diagnosis)
- 25(OH)D3 Serum Levels(study duration maximum 3.5 years (Treatment period) or until relapse)
- Stage of Melanoma Patient(Time at diagnosis)