Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients by bioimpedance analysis ( BIA)
研究概览
简要总结
Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in patients with tumors in the high gastro-intestinal tract, liver, pancreas and bile ducts in palliative treatment.
详细描述
- Compare muscle mass values obtained before and after the use of anabolic steroids upon assessment by bioelectrical impedance analysis (BIA).
- Compare the anabolic effect on quality of life (QLo) of the patient before and after the use of anabolic steroids.
- Compare data from laboratory tests such as complete blood count, albumin, C reactive protein and transferrin with drug intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The outcomes assessor and investigator does not have contact with the patient or care provider at the moment of randomization and the study purpose. The investigator just apply the bioelectrical impedance analysis and helps the patient about doubts on the Quality of Life questionnaire of EORTC ( QLQ-C30)
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
- •Cancer patients above 18 years old.
- •Patients with tumors in the high gastro-intestinal, hepatobiliary and pancreatic tracts in palliation.
- •Patients able to undergo BIA.
- •Malnourished patients as per the subjective global assessment produced by the patient (ASG-PPP) and whose score is greater than nine.
- •Patients who agree to participate in the study.
排除标准
- •Patients with malignant tumors of other metachronous or synchronous location except nonmelanoma skin tumor
- •Patients with chronic renal failure.
- •Patients on diuretics, recent or chronic.
- •Patients on appetite stimulants and anabolic agents.
- •Patients using pacemakers, which can interfere with the results of BIA
研究组 & 干预措施
Group 1: nandrolone and corticosteroid
the patient will receive an application of anabolic nandrolone decanoate at a dose of 50 mg (males) and 25 mg (females), intra-muscular form, in the first and fifteenth days. In addition to the anabolic steroid, the patient will use corticosteroids (dexamethasone) at home at a dose of 4 mg daily by mouth on the morning for both sexes for 30 days.
干预措施: Nandrolone Decanoate (Drug)
Group 2: corticosteroid
Patient will take corticosteroids ( 4 mg of dexamethasone) per oral, QD at morning for 30 days
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients by bioimpedance analysis ( BIA)
时间窗: After 30 days, the values will be compared to those obtained on the first consultant.
Evaluate the BIA (biometrical impedance analysis)trough the reactance and resistance in ohms and the phase angle in degree.
Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients
时间窗: After 30 days, the values will be compared to those obtained on the first consultant.
Evaluate the BMI ( body mass index)- the weight in kilograms and the height in centimeters and BMI in Kg/ m2.
ompare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients trough quality of life assessment
时间窗: After 30 days, the values will be compared to those obtained on the first consultant.
Evaluate quality of life by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnare Core 30 ( QLQ-C30), version 3.0 . The values are expressed as a percentage
次要结局
- Compare data from laboratory tests: complete blood count, albumin, C reactive protein and transferrin with drug intervention.(After 30 days, the laboratory test will be collect again and the values will be compared to those obtained on the first consultant.)