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

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

NCT ID: NCT06532149

Condition: NSCLC Stage IV
Sex Disorder
Hypogonadism, Male
Erectile Dysfunction

Conditions: Official terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Hypogonadism
Eunuchism
Carboplatin
Pembrolizumab
Nivolumab
Pemetrexed
Trametinib
Osimertinib
Cemiplimab
Dabrafenib
Sotorasib
Alectinib

Conditions: Keywords:
NSCLC
Sexual Health
Male hypogonadism
Erectile Dysfunction

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Alectinib
Description: Alectinib 600 mg/BID
Arm group label: Cohort A

Other name: Alecensa

Intervention type: Drug
Intervention name: Brigatinib
Description: 180 mg/daily
Arm group label: Cohort A

Other name: ALUNBRIG

Intervention type: Drug
Intervention name: Lorlatinib 100 mg
Description: 100 mg/daily
Arm group label: Cohort A

Other name: LORVIQUA

Intervention type: Drug
Intervention name: Osimertinib
Description: 80 mg/daily
Arm group label: Cohort B

Intervention type: Drug
Intervention name: Sotorasib
Description: 960 mg/daily
Arm group label: Cohort B

Intervention type: Drug
Intervention name: Dabrafenib
Description: 150 mg/BID
Arm group label: Cohort B

Intervention type: Drug
Intervention name: Trametinib
Description: 2 mg/daily
Arm group label: Cohort B

Intervention type: Drug
Intervention name: Selpercatinib
Description: 160 mg/BID
Arm group label: Cohort B

Intervention type: Drug
Intervention name: Pembrolizumab
Description: 200 mg intravenous every 21 days
Arm group label: Cohort C
Arm group label: Cohort D

Intervention type: Drug
Intervention name: Cemiplimab
Description: 350 mg intravenous every 21 days
Arm group label: Cohort C
Arm group label: Cohort D

Intervention type: Drug
Intervention name: Nivolumab
Description: 240 mg intravenous every 14 days
Arm group label: Cohort C
Arm group label: Cohort D

Intervention type: Drug
Intervention name: Carboplatin
Description: AUC4/AU5 intravenous every 21 days
Arm group label: Cohort D

Intervention type: Drug
Intervention name: Pemetrexed
Description: 500 mg/mq intravenous every 21 days
Arm group label: Cohort D

Intervention type: Drug
Intervention name: Paclitaxel
Description: 175 mg/mq intravenous every 21 days
Arm group label: Cohort D

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

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
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

Gender: Male

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fondazione Policlinico Gemelli IRCCS

Address:
City: Rome
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: Emilio Bria, Professor

Phone: 0630155202

Phone ext: +39
Email: emilio.bria@policlinicogemelli.it

Start date: August 5, 2024

Completion date: September 30, 2026

Lead sponsor:
Agency: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class: Other

Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06532149