Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes
研究概览
简要总结
Primary Objective:
- To determine the prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes.
Secondary Objective:
- To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male patients on chronic opioid therapy for cancer-related pain syndromes.
详细描述
Studies have shown that non-cancer patients taking opioid pain medication for a long period of time can have decreased libido and decreased sexual function.
Individuals may be asked to take part in this study even if they have not taken opioid pain medications in the last twelve months. These individuals would also be enrolled to learn if long-term treatment of cancer-related pain with opioid medications results in decreased sex hormones, decreased sex drive, and increased fatigue or depression.
Participants in this study will be asked to complete a set of questions about their sexual functions, physical symptoms, and psychological symptoms such as fatigue and depression. It will take about 25 minutes to complete the questionnaires.
Participants will have blood drawn (about 2 teaspoons of blood) to test their sex hormone level. Participants who are identified as having low sex hormone level (hypogonadism) will be referred to an endocrinologist for standard hormone replacement therapy.
This is a one-time evaluation, no follow-up visit or questionnaires are required.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Chronic pain greater than one year.
- •Cancer status must be stable or in remission. For this study, "stable disease" is defined as identifiable disease at local or metastatic sites that has shown no progression over the previous 3 months and there has been no cancer treatment for ³ 3 months.
- •Patients must be on chronic opioid therapy on a continuous basis in the preceding twelve months with a Morphine Equivalent Daily Dose (MEDD) ³
- •The questionnaires used in this study have been validated only in the adult population. In addition, some of the questionnaires contain questions of a sensitive nature and are not appropriate in the pediatric population.
- •Patients must be able to understand and sign the consent form.
排除标准
- •Patient who refuses to participate in the study or determined incapable of completing the research.
- •Patients with pre-existing hypopituitarism. Causes include certain tumors (pituitary adenomas, hypothalamic tumors), inflammatory diseases (granulomatous diseases), vascular diseases (postpartum necrosis, carotid aneurysm), traumatic/destructive events (prior surgery, trauma, or radiation), developmental anomalies, infiltration.
- •Patients who tare taking any drugs that may affect the hypothalamic-pituitary-gonadal axis.
结局指标
主要结局
Prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes
时间窗: 3 Years
次要结局
未报告次要终点