ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of treatment-related sexual dysfuction in male patients with ANSCLC
研究概览
简要总结
Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients.
The aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of advanced/metastatic NSCLC
- •To be candidate to active treatment
- •Aged ≥ 18 anni (up to 75 years old)
- •To be sexually active in last 30 days before treatment start
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Written informed consent
排除标准
- •History of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years
- •Any cancer-related or medical condition that would interfere with the patient reported outcomes or laboratory assessment. Examples include, but are not limited to:
- •Cancer-related conditions that may preclude/undermine sexual activity (e.g. leptomeningeal carcinomatosis, pathological vertebral fractures, gonadic metastases, unstable spinal cord compression, uncontrolled neurological symptoms, surgical complications):
- •History of chronic liver disease or hormonal replacement therapy (e.g. ADT for prostatic cancer)
- •Participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin)
- •Chronic use of drugs with known effect on male sexuality, including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers (e.g. atenolol) and high dose diuretics
- •Psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- •Major psychological disorder and/or high distress level that would interfere with sexual function and the participant's ability to cooperate with the requirements of the study
研究组 & 干预措施
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
干预措施: Nivolumab (Drug)
Cohort A
Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
干预措施: Alectinib (Drug)
Cohort A
Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
干预措施: Brigatinib (Drug)
Cohort A
Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
干预措施: Lorlatinib 100 mg (Drug)
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
干预措施: Osimertinib (Drug)
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
干预措施: Sotorasib (Drug)
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
干预措施: Dabrafenib (Drug)
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
干预措施: Trametinib (Drug)
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
干预措施: Selpercatinib (Drug)
Cohort C
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
干预措施: Pembrolizumab (Drug)
Cohort C
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
干预措施: Cemiplimab (Drug)
Cohort C
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
干预措施: Nivolumab (Drug)
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
干预措施: Pembrolizumab (Drug)
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
干预措施: Cemiplimab (Drug)
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
干预措施: Carboplatin (Drug)
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
干预措施: Pemetrexed (Drug)
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Incidence of treatment-related sexual dysfuction in male patients with ANSCLC
时间窗: From treatment start up to 1 year
Percentage of patients who reported any sexual health disorders after treatment start
次要结局
- Incidence of treatment-related erectile dysfuction in male patients with ANSCLC(From treatment start up to 1 year)
- Incidence of treatment-related hypogonadism in male patients with ANSCLC(From treatment start up to 1 year)
研究者
Bria Emilio
Prof.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS