Status:
RECRUITING
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
NSCLC Stage IV
Sex Disorder
Eligibility:
MALE
18-75 years
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-g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06532149
Start Date
August 5 2024
End Date
September 30 2026
Last Update
August 9 2024
Active Locations (1)
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1
Fondazione Policlinico Gemelli IRCCS
Rome, Italy, 00168