Actively Recruiting
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-08-09
80
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how advanced treatments for male patients with non-small cell lung cancer (NSCLC) affect sexual health and hormone levels. The study focuses on assessing the incidence of endocrine toxicity and sexual dysfunction, including erectile dysfunction, in men undergoing active cancer treatment. This research highlights an important but often overlooked aspect of quality of life in oncology, especially for younger patients receiving targeted therapies, immunotherapy, or chemotherapy. The study includes male patients with advanced or metastatic NSCLC who are actively receiving various anticancer treatments. Participants are grouped based on their cancer subtype and treatment type, including targeted drugs such as Alectinib, Brigatinib, Lorlatinib, Osimertinib, Sotorasib, Dabrafenib, Trametinib, and Selpercatinib, immunotherapy agents like Pembrolizumab, Cemiplimab, and Nivolumab, and chemotherapy drugs including Carboplatin, Pemetrexed, and Paclitaxel. Treatment dosages and schedules vary, with some drugs taken daily and others administered intravenously every 14 to 21 days. Participants will be monitored from the start of treatment for up to one year to track the occurrence of sexual dysfunction, hypogonadism, and erectile dysfunction. The study involves collecting patient-reported outcomes and laboratory assessments to measure these effects. Male patients must be sexually active prior to treatment and have good performance status. The trial is observational, with no placebo or control group, and aims to provide comprehensive data on how anticancer treatments impact male sexual health during therapy.
CONDITIONS
Brief Title
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC)
- Candidate for active anticancer treatment
- Male aged 18 to 75 years
- Sexually active in the 30 days before starting treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Provided written informed consent
You will not qualify if you...
- History of endocrine disorders except controlled hypothyroidism treated with levothyroxine for at least 2 years
- Any cancer-related or medical condition interfering with patient-reported outcomes or laboratory assessments
- Conditions precluding sexual activity such as leptomeningeal carcinomatosis, pathological vertebral fractures, gonadal metastases, unstable spinal cord compression, uncontrolled neurological symptoms, or surgical complications
- History of chronic liver disease or hormonal replacement therapy for prostate cancer
- Not fully recovered from previous chemotherapy-induced gonadotoxicity
- Chronic use of drugs known to affect male sexuality, including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers, and high-dose diuretics
- Psychiatric or substance abuse disorders interfering with study participation
- Major psychological disorders or high distress affecting sexual function and cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From treatment start up to 1 year
Participants who are receiving active anticancer treatment are observed to assess treatment-related sexual dysfunction and hypogonadism.
Regular visits according to treatment schedules
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
E
Emilio Bria, MD
E
Emanuele Vita, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here