ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
Recruiting · NCT06532149 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
AlectinibBrigatinibCarboplatinCemiplimabDabrafenibLorlatinib 100 mgNivolumabOsimertinibPaclitaxelPembrolizumabPemetrexedSelpercatinibSotorasibTrametinib
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
Who can take part
Age range
18 Years to 75 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Fondazione Policlinico Gemelli IRCCS - Rome, Italy