Actively Recruiting
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-08-09
80
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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
- Candidate for active treatment
- Male aged 18 to 75 years
- Sexually active in the last 30 days before treatment start
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Written informed consent provided
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 lab assessments
- Cancer conditions precluding or undermining sexual activity such as 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 like androgen deprivation therapy for prostate cancer
- Incomplete recovery from previous chemotherapy-induced gonadotoxicity
- Chronic use of drugs affecting male sexuality including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers, and high dose diuretics
- Psychiatric or substance abuse disorders interfering with study cooperation
- Major psychological disorders or high distress levels impacting sexual function or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
E
Emilio Bria, MD
CONTACT
E
Emanuele Vita, MD
CONTACT
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
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