NCT06532149 ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
| NCT ID | NCT06532149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | NSCLC Stage IV |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2026-09-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-08-05 with a primary completion date of 2026-09-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06532149 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 75 Years, studying NSCLC Stage IV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06532149 currently recruiting?
Yes, NCT06532149 is actively recruiting participants. Contact the research team at emilio.bria@policlinicogemelli.it for enrollment information.
Where is the NCT06532149 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06532149 clinical trial?
NCT06532149 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 80 participants.