An observational study in NSCLC Stage IV, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
The experimental Cohort A (male ALK+ ANSCLC patients receiving alectinib), the control Cohort B (female ALK+ ANSCLC patients receiving alectinib) and control Cohort C (male NON-ALK ANSCLC patients) were prospectively evaluated for full hormone assessment of androgen deficiency, AT 8 weeks after treatment start and in case of reported suspected symptoms. Patients with major sexual dysfunctions were referred to endocrinologist.
Male patients (Cohorts A-C). After 8 weeks from treatment start (T1), as the same time of initial endocrine evaluation, we assessed symptoms of androgen deficiency by using the Androgen Deficiency in Aging Males (ADAM) questionnaire (Supplementary, SD1), a validated screening assessment of hypogonadism in adult males [15]. Next, the questionnaire was collected every 12 weeks during the routine clinic visits up to three years (if considered clinically appropriated). The response to the questionnaire was considered consistent with possible hypogonadism (i.e. positive), if the patient reported at least one major symptom (loss of libido and/or impotence; questions 1 and 7) or at least three minor symptoms. In case of suspected hypogonadism at ADAM questionnaire, hormonal tests were again performed and the patient was referred to Andrology Unit of the Endocrinology Departement in case of abnormal results. Andrology visit included physical examination, testicular and scrotum ultrasound, medical history and hormonal tests reviewing; when testosterone replacement and/or drugs for erectile dysfunction were prescribed, the overall effectiveness on symptoms of hypogonadism (improved/not improved) was assessed by the andrologist and checked at next oncologic visits.
Female patients (Cohort B). After 8 weeks from treatment start (T1), as the same time of initial endocrine assessment, we assessed symptoms of sexual dysfunctions, according to menopausal status, by using the EORTC QLQ - BR23 and FACT-B (Version 4) questionnaires. In case of clinically significant gynaecological symptoms and/or abnormal results of sexual hormones axis in relation to menopausal status, the patients were referred to multidisciplinary evaluation by an endocrinologist and a gynaecologist. Multidisciplinary evaluation included physical and gynaecological examination, pelvic ultrasound, medical history and hormonal tests reviewing; diagnosis and treatment of endocrine/gynaecological dysfunction and prescribed treatment/intervention were reported in medical history and checked at next oncologic visits
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 98 is below the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.
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TOSS-ALK is single-Institution observational prospective sex-based trial aimed to assess endocrine toxicity in ALK+ advanced/metastatic ANSCLC male patients treated with first-line alectinib (Cohort A). As control cohorts, we included female ALK+ ANSCLC patients (Cohort B) and male patients with NON-ALK+ NSCLC who are receiving active treatment (ACT) according to tumour molecular profiling (Cohort C).
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Exclusion Criteria:
2a. 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)
2b. History of chronic liver disease or hormonal replacement therapy (e.g. ADT for prostatic cancer)
2c. Participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin)
2d. 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
2e. Psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
2f. 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
Male ALK-positive ANSCLC patients receiving first-line treatment with alectinib
Drug: Alectinib 150 MG [Alecensa]
Female ALK-positive ANSCLC patients receiving first-line treatment with alectinib
Drug: Alectinib 150 MG [Alecensa]
Male ALK-negative ANSCLC patients receiving first-line treatment according to molecular profiling
First line treatment for cohorts A and B
Also known as: Alecensa
Incidence of endocrine toxicity in overall ALK-positive
Percentege of endocrine alterations among patients included in Cohort A and B
Time frame: Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Incidence of symptomatic hypogonadism in male ANSCLC patients
Percentage of endocrine alterations and/or clinical sexual dysfuctions among male patients included in Cohort A and C
Time frame: Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
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