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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how advanced lung cancer and its treatments can impact men's sexual health and hormone levels. Specifically, it aims to find out how often men with Stage IV non-small cell lung cancer (NSCLC) experience issues like erectile dysfunction and hormonal changes during their treatment. This is important because, while many cancer studies look at quality of life, male sexual health is often overlooked, even though it can significantly affect a patient's overall well-being.

To participate in this study, men must be between 18 and 75 years old, diagnosed with advanced NSCLC, and planning to start active treatment. They should also have been sexually active in the month before starting treatment. Participants will be asked to provide informed consent and will undergo assessments regarding their sexual health and hormone levels throughout the trial. It's essential to note that certain medical conditions or treatments may exclude someone from joining, especially if they could interfere with the study's findings. Overall, this trial aims to shed light on an important aspect of life that can be affected by cancer treatment, helping to improve support for men facing these challenges.

Gender

MALE

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