Testosterone supplementation in patients in best supportive care: impact on quality of life.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Best improvement over time in independence using the ADL independence scale in terms of personal hygiene, dressing, going to the toilet, locomotion, continence and eating
研究概览
简要总结
To evaluate the impact of testosterone supplementation on the quality of life of male patients in best supportive care with no therapeutic options left and who do not wish to be reanimated.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Main Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male hypogonadal cancer patient with total testosterone < 231 ng/dl receiving best supportive care with no further therapeutic options and who do not wish to be reanimated.
- •Age ≥ 18 years old
- •Patient able to understand the patient information sheet and able to sign the Informed Consent form (ICF) prior to any study related procedure
排除标准
- •Untreated relapsed or metastatic prostate cancer, given the risk of epiduritis.
- •Known hypersensitivity reactions to the study drug or to any excipients
- •Known allergies to peanuts or soya.
结局指标
主要结局
Best improvement over time in independence using the ADL independence scale in terms of personal hygiene, dressing, going to the toilet, locomotion, continence and eating
Best improvement over time in independence using the ADL independence scale in terms of personal hygiene, dressing, going to the toilet, locomotion, continence and eating
Best improvement over time in symptoms of pain, fatigue, sadness, anxiety, drowsiness, appetite, sense of well-being, shortness of breath, bowel movements and strength using the Edmonton Symptom Assessment Scale
Best improvement over time in symptoms of pain, fatigue, sadness, anxiety, drowsiness, appetite, sense of well-being, shortness of breath, bowel movements and strength using the Edmonton Symptom Assessment Scale
次要结局
- The average of ADL and Edmonton Symptom Assessment Scale during treatment after baseline. The ADL and Edmonton System Assessment Scale at each time point during treatment, especially at D15.
- Improvement of quality of life of subjects from the point of view of a proxy using the EQ-5D-3L questionnaire.
研究者
CTSU
Scientific
Institut Jules Bordet