'Palliative-D' Vitamin D Supplementation to Palliative Cancer Patients - A Double Blind, Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 3
- 主要终点
- Change in opioid dose during 12 weeks
研究概览
简要总结
To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients can decrease opioid consumption, fatigue and infectious burden and increase quality of life.
详细描述
PROTOCOL IDENTITY AND OBJECTIVES: EudraCT Number 2017-000268-14 Protocol Title: Vitamin D supplementation to palliative cancer patients - A double blind, randomised controlled trial. Acronym: "Palliative-D" Trial Objectives: To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients can decrease opioid consumption, fatigue and infectious burden and increase quality of life.
INVESTIGATIONAL MEDICINAL PRODUCTS (IMP): Test ProductDetremin, MA holder Renapharma; Pharmaceutical Form: Oil Route of Administration: Oral route
METHODOLOGY Trial Design: Double-blind, parallel randomised and placebo controlled trial Dose/Duration 4000 IU/day for 12 weeks
Primary Endpoint:
The decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 3 measurements with 4 weeks intervals.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to ASIH Stockholm Södra or Stockholms Sjukhem.
- •Incurable cancer patients with any type of cancer. They could have ongoing oncological treatment but only with palliative intention. No patients with ongoing oncological treatment with curative intended treated will be included.
- •The life expectancy should be at least 3 months according to the clinical assessment of the study physician at the screening visit.
- •The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
- •25 OHD < 50 nmol/L.
- •Men and women aged ≥18
- •Signed 'informed consent'
排除标准
- •Ongoing vitamin D supplementation at the time for inclusion.
- •Serum level of 25-OH vitamin D3 >50 nmol/L
- •Known sarkoidosis
- •Treatment with tiazides or digoxin or digitoxin
- •Primary hyperparathyroidism
- •Hypercalcaemia (verified by a laboratory result younger than 2 month)
- •Plans to leave the Stockholm county within 12 weeks of inclusion
- •History of kidney stones
- •Taking part of another clinical study involving drugs
- •Hypersensitivity to cholecalciferol and/or any of the excipients
- •Other criteria that could jeopardize the study or its intention as judged by the investigator
- •Not being able to perform EORTC-QLQ-C15-PAL or ESAS
研究组 & 干预措施
Vitamin D
Cholecalciferol (Detremin) solved in MIGLYOL® 812
干预措施: Cholecalciferol (Drug)
Placebo
MIGLYOL® 812
干预措施: Placebo (Device)
结局指标
主要结局
Change in opioid dose during 12 weeks
时间窗: 12 weeks
The change in decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 4 measurements with 4 weeks intervals.
次要结局
- Change in 25-hydroxyvitamin D levels after 12 weeks(12 weeks)
- Change in Quality of life after 12 weeks(12 weeks)
- Change in Fatigue after12 weeks(12 weeks)
- Change in Antibiotic Consumption during 12 weeks(12weeks)
- Change in Symptom burden during 12 weeks(12 weeks)
研究者
Linda Björkhem-Bergman
MD, PhD, Assoc Prof, Senior Consultant
Region Stockholm