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NCT Number: NCT06532149

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

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

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alectinib

Drug

Alectinib 600 mg/BID

Other names: Alecensa

Brigatinib

Drug

180 mg/daily

Other names: ALUNBRIG

Lorlatinib 100 mg

Drug

100 mg/daily

Other names: LORVIQUA

Osimertinib

Drug

80 mg/daily

Sotorasib

Drug

960 mg/daily

Dabrafenib

Drug

150 mg/BID

Trametinib

Drug

2 mg/daily

Selpercatinib

Drug

160 mg/BID

Pembrolizumab

Drug

200 mg intravenous every 21 days

cemiplimab

Drug

350 mg intravenous every 21 days

Nivolumab

Drug

240 mg intravenous every 14 days

carboplatin

Drug

AUC4/AU5 intravenous every 21 days

Pemetrexed

Drug

500 mg/mq intravenous every 21 days

paclitaxel

Drug

175 mg/mq intravenous every 21 days

Primary outcomes

  1. Incidence of treatment-related sexual dysfuction in male patients with ANSCLC

    Time frame: From treatment start up to 1 year

    Percentage of patients who reported any sexual health disorders after treatment start

Secondary outcomes

  1. Incidence of treatment-related hypogonadism in male patients with ANSCLC

    Time frame: From treatment start up to 1 year

    Percentage of patients who reported reduction of testosterone levels after treatment start

  2. Incidence of treatment-related erectile dysfuction in male patients with ANSCLC

    Time frame: From treatment start up to 1 year

    Percentage of patients who erectile dysfuction after treatment start

Study contacts

Contact information is provided by the study sponsor or research team.

Emanuele Vita, MD

CONTACT

[email protected]

0630156318

Emilio Bria, MD

CONTACT

[email protected]

0630156318

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: EROS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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