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Recruiting NCT06532149

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

— Observational NSCLC Stage IV Sex Disorder Hypogonadism, Male Erectile Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alectinib, Brigatinib, Lorlatinib 100 mg, Osimertinib.
Who it may be relevant to
Registry conditions: NSCLC Stage IV, Sex Disorder, Hypogonadism, Male, Erectile Dysfunction. Basic parameters: 18 years — 75 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)

Overview

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

  • Drug Alectinib
    Alectinib 600 mg/BID
  • Drug Brigatinib
    180 mg/daily
  • Drug Lorlatinib 100 mg
    100 mg/daily
  • Drug Osimertinib
    80 mg/daily
  • Drug Sotorasib
    960 mg/daily
  • Drug Dabrafenib
    150 mg/BID
  • Drug Trametinib
    2 mg/daily
  • Drug Selpercatinib
    160 mg/BID
  • Drug Pembrolizumab
    200 mg intravenous every 21 days
  • Drug Cemiplimab
    350 mg intravenous every 21 days

Primary outcome measures

  • Incidence of treatment-related sexual dysfuction in male patients with ANSCLC [Time frame: From treatment start up to 1 year]
Secondary outcome measures (2)
  • Incidence of treatment-related hypogonadism in male patients with ANSCLC [Time frame: From treatment start up to 1 year]
  • Incidence of treatment-related erectile dysfuction in male patients with ANSCLC [Time frame: From treatment start up to 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Gemelli IRCCS — Rome

Identifiers

NCT: NCT06532149 · 6578

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗