RecruitingNCT06532149

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

80 participants

Start Date

Aug 5, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how lung cancer and its treatments affect sexual health and hormone function in men. Researchers want to understand if treatments for advanced non-small cell lung cancer (NSCLC) cause problems like erectile dysfunction or changes in hormone levels — and how often these issues occur — so that doctors can better support male patients going through treatment. **You may be eligible if...** - You have been diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) - You are a man aged 18 to 75 - You were sexually active in the 30 days before starting treatment - You are starting active cancer treatment - You are in reasonably good health (ECOG 0-1) **You may NOT be eligible if...** - You have a history of hormone disorders (other than controlled thyroid disease) - You take medications known to affect sexual function (such as opioids, antidepressants, beta-blockers, or certain diuretics) - You have conditions that make sexual activity impossible (such as spinal cord compression or serious nerve issues) - You have a major psychological disorder that would interfere with the study - You previously received chemotherapy that caused lasting damage to your reproductive system (such as cisplatin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlectinib

Alectinib 600 mg/BID

DRUGBrigatinib

180 mg/daily

DRUGLorlatinib 100 mg

100 mg/daily

DRUGOsimertinib

80 mg/daily

DRUGSotorasib

960 mg/daily

DRUGDabrafenib

150 mg/BID

DRUGTrametinib

2 mg/daily

DRUGSelpercatinib

160 mg/BID

DRUGPembrolizumab

200 mg intravenous every 21 days

DRUGCemiplimab

350 mg intravenous every 21 days

DRUGNivolumab

240 mg intravenous every 14 days

DRUGCarboplatin

AUC4/AU5 intravenous every 21 days

DRUGPemetrexed

500 mg/mq intravenous every 21 days

DRUGPaclitaxel

175 mg/mq intravenous every 21 days


Locations(1)

Fondazione Policlinico Gemelli IRCCS

Rome, Italy

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NCT06532149


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