Randomized Controlled Trial on the Effect of Vitamin C Supplementation in Autologous Stem Cell Transplantations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- immune recovery
研究概览
简要总结
In the study the investigators will randomize patients that receive an autologous stem cell transplantation for myeloma or lymphoma for treatment with vitamin C or placebo during 6 weeks. Primary endpoint will be immune recovery.
详细描述
Rationale: Recent studies showed that ascorbic acid (AA) stimulates proliferation and maturation of T lymphocytes and natural killer (NK) cells. Chemotherapy results in depletion of those cells and thereby an increased infection rate. A pilot study showed low levels of AA in the plasma of several patients after chemotherapy followed by autologous stem cell transplantation for hematological malignancies. AA supplementation could be beneficial to the recovery of the immune system in these patients.
Objective: The aim of this study is to examine the effect of vitamin C supplementation on immune recovery in patients with autologous stem cell transplantation. The aim of the run-in phase of the study is to examine the effect of intravenous vitamin C supplementation on plasma concentrations of vitamin C in patients with autologous stem cell transplantation at day 14 in order to be sure that in the intervention study accurate AA plasma levels will be present.
Study design: run-in phase, followed by randomized controlled trial Study population: All participants will be adults (minimally 18 years old) that are planed to receive an autologous stem cell transplantation for multiple myeloma or lymphoma and are recruited at the MUMC+. In total there will be 3 expected (run-in phase) + 44 (randomized controlled trial) participants.
Main study parameters/endpoints: Primary endpoints will be AA plasma level on day 14 (run-in phase) and the day of neutrophil recovery after stem cell transplantation (randomized-controlled phase). Secondary endpoints will be AA leukocyte levels, infection rate, duration of hospital stay, side effects of chemotherapy, overall survival, coagulation parameters, platelet reactivity, fibrinolysis and quality of life.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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
- •18 years or older
- •written informed consent
- •diagnosis of malignant lymphoma or multiple myeloma
- •require chemotherapy plus autologous stem cell transplantation as standard of care for the disease at that stage
- •central venous catheter in place or planned
排除标准
- •inability to understand the nature and extent of the trial and the procedures required
- •history of kidney stones
- •kidney failure requiring dialysis or eGFR <30 mL/min. (CDK-EPI formula)
- •history of G6PD deficiency
- •life expectancy < 1 month
- •use of immunosuppressive medication other than chemotherapy and corticosteroids
研究组 & 干预措施
Vitamin C
vitamin C intravenous during hospitalization, followed with vitamin C oral
干预措施: Vitamin C (Drug)
Placebo
placebo intravenous during hospitalization, followed with placebo oral
干预措施: Placebos (Drug)
结局指标
主要结局
immune recovery
时间窗: day 14-28
the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.
次要结局
- platelet reactivity(day 10)
- Incidence of infections/ neutropenic fever(day 1-28)
- Incidence of bloodstream infections(day1-28)
- Relapse rates (3 months)(3 months)
- Use of systemic antimicrobial agents (incidence and duration)(dau 1-28)
- AA plasma levels(day 14)
- Days with fever (≥ 38.5° C)(day 1-28)
- AA leukocyte levels(day 14)
- Days of hospitalization(dag 1-28)
- ROS production(day 10)
- Quality of life according to the EORTC QLQ-C30(Day 0, day 14, day 42)
- Overall survival (3 months)(3 months)
- platelet mitochondrial dysfunction(day 10)
- number and severity of bleeding episodes during admission(day 1-28)