Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer: A Double Blinded Clinical Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 134
- 试验地点
- 3
- 主要终点
- Change in oxygen uptake at the anaerobic threshold
研究概览
简要总结
This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study.
Study outline:
After initial inclusion the patient will undergo baseline testing with cardiopulmonary exercise test (CPET), then followed by an infusion of a weight dependent dosage of iron(III)isomaltoside or placebo. Then at the closest possible time to the surgery the patient will have drawn bloodwork and be re-tested by (CPET). The patient will be followed after surgery with evaluation of several outcomes including quality of recovery and complications. Further, the effects of the intervention on the patients immune function will be evaluated by two different methods: 1) by changes in neutrophil-to-lymphocyte ratio between baseline and preoperative bloodwork and 2) by evaluation mRNA expression in the tumor specimen by the Nanostring pancancer immune panel
详细描述
Aim The aim is to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery.
Study design The study will be performed as a double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group. The study will be performed as a multicenter study with inclusion at Department of Surgery, Zealand University Hospital, Departement of Surgery, Slagelse Hospital and Department of Surgery, Regionshospital Randers. The study will need 134 participants, 67 in each arm.
Potential patients will be identified through routine blood samples taken prior to the first consultation. The samples will contain a complete anemia workup and a white blood cell count. The clinical guidelines for identifying and treating anemia in patients with colorectal cancer prior to surgery defines anemia by a hemoglobin ≤ 7 mmol/L for both men and women. Therefore non-anemic patients are defined by a hemoglobin above 7 mmol/L for both men and women in this protocol. Patients, who consents to the study, will immediately after the consultation be randomized and given weight dependent dose of Monofer® (Iron(III)-Isomaltoside) or placebo. On the day prior to surgery (or closest possible time) blood samples similar to the previous samples, will be taken, but with two additional blood samples, which will be stored for later analysis.
At the day of surgery, samples from the invasive front of the removed tumor will be taken and stored for later analysis by the Nanostring PanCancer Immune panel.
The first 20 patients from the Zealand University Hospital and Slagelse hospital will be physical tested by CPET prior to randomization and the day prior to surgery.
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)
盲法说明
Concealement by opaque infusion bags and iv. drips.
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
- •Planned for curative intended elective colon or rectum cancer surgery
- •UICC stage I-III (at diagnosis)
- •Hemoglobin > 7.0 mmol/L
- •Serum ferritin <101 microgram/L or transferrin saturation <21%
排除标准
- •Chronic kidney failure with need for dialysis
- •Metachronous diagnosed cancer
- •Unable to speak or understand Danish
- •Cognitive impairment e.g. moderate to severe dementia
- •Concurrent severe active bacterial infection
- •Known allergy for Iron(III)isomaltoside
- •Contraindications for intravenous iron (Pofryria, livercirrosis, active hepatitis, transaminases three times the upper limit, hemosiderosis and hemochromatosis)
- •Withdrawal of informed consent
- •Neoadjuvant chemo or radiation therapy
- •Pregnancy
研究组 & 干预措施
Iron(III)isomaltoside 1000
Weight-dependent one-time dosage of intravenous administration of iron(III)isomaltoside given prior to surgery. Dosage: <50 kg body weight = 500 mg, 50-59 kg body weight = 600 mg, 60-59 kg body weight = 700 mg, 70-79 kg body weight = 800 mg, 80-89 kg body weight = 900 mg, and 90+ kg body weight = 1000 mg.
干预措施: Iron(III)isomaltoside (Drug)
Placebo
500 ml isotonic saline infusion fluid
干预措施: Placebo (Drug)
结局指标
主要结局
Change in oxygen uptake at the anaerobic threshold
时间窗: at baseline and 1-4 days before surgery
Change in oxygen uptake at the anaerobic threshold measured by cardiopulmonary exercise test before infusion and the days before surgery
Change in neutrophile to lymphocyte ratio (NLR)
时间窗: at baseline and 1-4 days before surgery
Change in neutrophile to lymphocyte ratio (NLR) between baseline bloodwork and prior to surgery.
Changes in T-cell function - mRNA expression analysis
时间窗: 1 day after surgery
Nanostring pancancer immune analysis of tumor samples
次要结局
- Quality of Recovery 15 (QoR-15)(Up to 7 days after surgery)
- Complications(30-days after surgery)
- Days alive and out of hospital - 30(30 days after surgery)
- 1 year cancer free survival(1 year after surgery)
- 5 year cancer free survival(5 years after surgery)