Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Evaluation of the quality of life of patients with iron deficiency with or without anemia during treatment for their cancer
研究概览
简要总结
In oncology, anemia is a frequent symptom, leading to complication of patient management for, more or less, a long term but often poorly evaluated by medical teams.
In oncology, anemia is induced by multiple causes. Iron deficiency appears to be a leading cause of anemia, especially in people with solid cancer. Iron deficiency is characterized by a low level of iron . Iron is a trace element required for life. It is a major component of hemoglobin allowing the transport of oxygen in red blood cells. There are in fact 2 types of iron deficiency: an absolute iron deficiency with a deficiency of true iron and a functional iron deficiency. Since end of January 2014, intravenous iron-based injections have been reclassified for cancer patients at ICO Paul Papin. The monitoring of iron deficiency with or without anemia is currently done in our institute, the ICO-Paul Papin. There is a procedure for the management of anemia with or without iron deficiency but there is still no traceability of treatments performed, their compliance or even their impact on the rate hemoglobin and the quality of life of patients during their treatment. This observatory also makes it possible to evaluate the impact of this treatment on the quality of life of the patients and thus allows them a personalized care of the tiredness during their treatment
详细描述
The study is for patients with iron deficiency and / or anemia during treatment for cancer These patients will receive ferinject. Patients will perform functional assessments and complete quality of life questionnaires, when the ferinject will be injected, then at 1 month and 6 months.
Patients will be followed for 6 months in the study
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patient with cancer regardless of the location
- •Patient with specific treatment (chemotherapy +/- targeted therapy and / or radiotherapy, hormone therapy or surgery)
- •Patient with Functional Iron Deficiency or absolute with or without anemia
- •Having given written informed consent prior to any procedure related to the study.
排除标准
- •Patient in a palliative situation not receiving specific treatment for their cancer
- •Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations
- •Patient with myeloproliferative disease
- •Contraindication to treatments for iron deficiency and / or anemia
- •Pregnant woman, parturient or nursing mothers
- •Patient has no valid health insurance
- •Disorder precluding understanding of trial information or informed consent
研究组 & 干预措施
Arm with Ferinject
Ferinject will be administered once at inclusion
干预措施: Ferinject (Drug)
结局指标
主要结局
Evaluation of the quality of life of patients with iron deficiency with or without anemia during treatment for their cancer
时间窗: 42 months
Obtained with the quality of life with the FACT-An questionnaire.
次要结局
- Estimation of the proportion of asymptomatic anemia(42 months)
- Estimation of the proportion of iron deficiency as a whole(42 months)
- Estimation of the proportion of absolute iron deficiency(42 months)
- Estimation of the proportion of functional iron deficiency(42 months)
- Estimation of the proportion of anemia as a whole(42 months)
- Estimation of the evolution of the functional capacities of the patient(42 months)
- Estimation of the proportion of undernourished patients(42 months)
- Estimation proportion of symptomatic anemia(42 months)