Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339554
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
Alectinib-induced Endocrine Toxicity
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Alectinib-induced Endocrine Toxicity in Patients With ALK-positive Advanced NSCLC an Onservational Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOSS-ALK
Brief Summary:
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
Detailed Description:
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 ie positive if the patient reported at least one major symptom loss of libido andor 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 andor drugs for erectile dysfunction were prescribed the overall effectiveness on symptoms of hypogonadism improvednot 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 andor 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 endocrinegynaecological dysfunction and prescribed treatmentintervention were reported in medical history 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 andor 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 endocrinegynaecological dysfunction and prescribed treatmentintervention were reported in medical history and checked at next oncologic visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None