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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

Qualifiers

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

Disqualifiers

History of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years

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

Trial design

Treatments tested in this trial

  • Alectinib
  • Brigatinib
  • Lorlatinib 100 mg
  • Osimertinib
  • Sotorasib
  • Dabrafenib
  • Trametinib
  • Selpercatinib
  • Pembrolizumab
  • Cemiplimab
  • Nivolumab
  • Carboplatin
  • Pemetrexed
  • Paclitaxel

Treatment groups

80 Participants
are divided into 4 treatment groups