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

ConditionsNSCLC Stage IVSex DisorderHypogonadism, MaleErectile Dysfunction
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

This trial does not accept healthy volunteers

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 population

Sexually active male patients diagnosed with advanced/metastatic NSCLC who are receiving active treatement according to their tumor molecular profiling

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Alectinib

    Drug

    Alectinib 600 mg/BID

  • Brigatinib

    Drug

    180 mg/daily

  • Lorlatinib 100 mg

    Drug

    100 mg/daily

  • 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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Cohort A3 interventions
Group B: Cohort B5 interventions
Group C: Cohort C3 interventions
Group D: Cohort D6 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
From treatment start up to 1 year

Secondary outcomes

1

Incidence of treatment-related hypogonadism in male patients with ANSCLC

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

Time frame
From treatment start up to 1 year
2

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

Percentage of patients who erectile dysfuction after treatment start

Time frame
From treatment start up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov
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