ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Fondazione Policlinico Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Emilio Bria, MD
emilio.bria@policlinicogemelli.it
0630156318
Backup
Emanuele Vita, MD
dr.emanuele.vita@gmail.com
0630156318
Time Frame
Start Date:2024-08-05
Estimated Completion Date:2026-09-30
Participants
Target number of participants:80
Treatments
Cohort A
Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
Cohort B
Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Cohort C
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
Cohort D
Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy