Clinical trial NCT06532149: ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
Official title: ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC Stage IV
Sex Disorder
Hypogonadism, Male
Erectile Dysfunction
Keywords: NSCLC
Sexual Health
Male hypogonadism
Erectile Dysfunction
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sexually active male patients diagnosed with advanced/metastatic NSCLC who are receiving active treatement according to their tumor molecular profiling

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

Primary outcomes:
measure: Incidence of treatment-related sexual dysfuction in male patients with ANSCLC
timeFrame: From treatment start up to 1 year
Secondary outcomes:
measure: Incidence of treatment-related hypogonadism in male patients with ANSCLC
timeFrame: From treatment start up to 1 year
measure: Incidence of treatment-related erectile dysfuction in male patients with ANSCLC
timeFrame: From treatment start up to 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
References: