ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)
Overview
- Phase
- Not Applicable
- Intervention
- Nivolumab
- Conditions
- NSCLC Stage IV
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-related sexual dysfuction in male patients with ANSCLC
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
Investigators
Bria Emilio
Prof.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Intervention: Nivolumab
Cohort A
Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
Intervention: Alectinib
Cohort A
Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
Intervention: Brigatinib
Cohort A
Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
Intervention: Lorlatinib 100 mg
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Intervention: Osimertinib
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Intervention: Sotorasib
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Intervention: Dabrafenib
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Intervention: Trametinib
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Intervention: Selpercatinib
Cohort C
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
Intervention: Pembrolizumab
Cohort C
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
Intervention: Cemiplimab
Cohort C
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
Intervention: Nivolumab
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Intervention: Pembrolizumab
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Intervention: Cemiplimab
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Intervention: Carboplatin
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Intervention: Pemetrexed
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Intervention: Paclitaxel
Outcomes
Primary Outcomes
Incidence of treatment-related sexual dysfuction in male patients with ANSCLC
Time Frame: From treatment start up to 1 year
Percentage of patients who reported any sexual health disorders after treatment start
Secondary Outcomes
- 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)