Erectile Dysfunction, Hypogonadism, Male, NSCLC Stage IV, Sex Disorder
Conditions
Keywords
NSCLC, Sexual Health, Male hypogonadism, Erectile Dysfunction
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
Interventions
DRUGAlectinib
Alectinib 600 mg/BID
DRUGBrigatinib
180 mg/daily
100 mg/daily
DRUGOsimertinib
80 mg/daily
DRUGSotorasib
960 mg/daily
DRUGDabrafenib
150 mg/BID
DRUGTrametinib
2 mg/daily
DRUGSelpercatinib
160 mg/BID
DRUGPembrolizumab
200 mg intravenous every 21 days
DRUGCemiplimab
350 mg intravenous every 21 days
DRUGNivolumab
240 mg intravenous every 14 days
DRUGCarboplatin
AUC4/AU5 intravenous every 21 days
DRUGPemetrexed
500 mg/mq intravenous every 21 days
DRUGPaclitaxel
175 mg/mq intravenous every 21 days
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related sexual dysfuction in male patients with ANSCLC | From treatment start up to 1 year | Percentage of patients who reported any sexual health disorders after treatment start |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related hypogonadism in male patients with ANSCLC | From treatment start up to 1 year | Percentage of patients who reported reduction of testosterone levels after treatment start |
| Incidence of treatment-related erectile dysfuction in male patients with ANSCLC | From treatment start up to 1 year | Percentage of patients who erectile dysfuction after treatment start |
Countries
Italy
Contacts
Primary ContactEmilio Bria, MD
Backup ContactEmanuele Vita, MD
Outcome results
None listed