Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Quality of life assessed by ADL questionnaire
研究概览
简要总结
This is a monocentric, single-arm prospective pilot study that will enrol hypogonadal (testosterone < 231 ng/dL) male subjects in best supportive care, with no further therapeutic options and no need for resuscitation.
Currently, testosterone formulations for intramuscular (IM) injection and subcutaneous injection as well as for oral and transdermal administration have been approved for androgen therapy. To date, injectable testosterone is the most commonly used formulation. To increase serum testosterone levels to the physiological range IM injections of testosterone every 2-3 weeks are required, which lead to supraphysiological peaks shortly after administration, followed by a sharp fall in levels thereafter. Testosterone levels before the next injection are frequently in the hypogonadal range. For this reason, Sustanon 250® (1 ml, IM) will be administered on day 0 after confirmation of hypogonadism by blood test and then every 15 days in this trial given the limited life expectancy of the subjects and to maximise the effect and benefit of testosterone supplementation.
The Edmonton questionnaire and ADL questionnaire will be completed before the injection on day 0 and then every 15 days at the time of injection until subject's death or if a subject is discontinued from the study treatment/procedures for any other reasons than death. In parallel, the EQ-5D-3L questionnaire will be completed by a family member or a proxy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male hypogonadal with total testosterone < 231 ng/dl in 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 prostate cancer, given the risk of epiduritis.
- •Known hypersensitivity reactions to the study drug or to any excipients.
- •Known allergies to peanuts or soya.
研究组 & 干预措施
Testosterone supplementation in patients in best supportive care: impact on quality of life
Single-arm prospective pilot study that will enrol hypogonadal (testosterone < 231 ng/dL) male subjects in best supportive care, with no further therapeutic options and no need for resuscitation.
Administration of Sustanon 250® (1 ml, IM) on day 0 after confirmation of hypogonadism by blood test and then every 15 days.
干预措施: Sustanon 250 (Drug)
结局指标
主要结局
Quality of life assessed by ADL questionnaire
时间窗: Every 15 days through study completion
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. The primary endpoint is defined as the difference between the best score after baseline and the initial score at baseline.
Quality of life assessed by Edmonton Symptom Assessment Scale
时间窗: Every 15 days through study completion,
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. The primary endpoint is defined as the difference between the best score after baseline and the initial score at baseline.
次要结局
- EQ-5D-3L questionnaire(Every 15 days through study completion)
- Dynamic/change of the ADL and Edmonton System Assessment Scale during treatment(At each time point during treatment, especially at Day 15.)