Assessing sexual health in men with advanced lung cancer
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)
This study is trying to see how new cancer treatments affect sexual health in men with advanced lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT06532149 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the incidence of endocrine toxicity and sexual dysfunction in male patients undergoing active treatment for advanced non-small cell lung cancer (NSCLC). It focuses on understanding the impact of new-generation anticancer therapies on male sexual health, which has been largely overlooked in oncology research. The study will involve sexually active men aged 18 to 75 who are candidates for treatment with specific targeted therapies and immunotherapies. Participants will be monitored for changes in sexual health and endocrine function throughout their treatment.
Who should consider this trial
Good fit: Ideal candidates are sexually active men aged 18 to 75 diagnosed with advanced or metastatic NSCLC who are eligible for active treatment.
Not a fit: Patients with a history of significant endocrine disorders or other medical conditions that could interfere with sexual activity or assessment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the sexual health challenges faced by men with lung cancer, leading to improved management strategies.
How similar studies have performed: While there is limited data on this specific focus, other studies have highlighted the importance of addressing sexual health in cancer care, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rome
- Fondazione Policlinico Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Emilio Bria, MD
- Email: emilio.bria@policlinicogemelli.it
- Phone: 0630156318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.