Actively Recruiting
A Potential Relationship Between Treatment With Tyrosine Kinase Inhibitors and Erectile Dysfunction in Male Patients With Chronic Myeloid Leukemia
Led by Azienda USL Reggio Emilia - IRCCS · Updated on 2025-08-06
350
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying male patients with chronic myeloid leukemia (CML), a blood cancer characterized by the Philadelphia chromosome causing abnormal enzyme activity. This trial focuses on the possible link between treatment with tyrosine kinase inhibitors (TKIs) and the development of erectile dysfunction (ED). The study addresses concerns about long-term side effects of TKIs, including vascular and hormonal changes, by evaluating ED incidence and its relationship with cardiovascular disease in men undergoing TKI therapy. The study is observational and includes both retrospective and prospective parts. It involves male CML patients aged 18 to 75 who started frontline TKI treatment between January 2015 and January 2022. Data collected retrospectively include medical records about ED onset, clinical assessments, blood tests, molecular monitoring of leukemia, and heart monitoring every six months. Prospectively, patients will be followed for two years to monitor ED development, cardiovascular events, and possible ED improvement after stopping therapy. Participants will provide informed consent and undergo routine clinical evaluations without additional experimental procedures. Researchers will measure the cumulative incidence of ED over 24 months, compare ED frequency by TKI type, observe ED resolution in some patients, and assess cardiovascular toxicity linked to ED. The study aims to better understand the impact of TKI treatment on men's sexual health and cardiovascular risks during and after therapy.
CONDITIONS
Brief Title
A Potential Relationship Between Treatment With Tyrosine Kinase Inhibitors and Erectile Dysfunction in Male Patients With Chronic Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with chronic phase Philadelphia chromosome-positive (Ph+) and/or BCR-ABL-positive CML
- Patients starting frontline treatment with TKIs between 01st January 2015 and 31st January 2022
- Age greater than or equal to 18 years and not exceeding 75 years at the time of starting therapy
- Male sex
- Exposure to Hydroxyurea or Anagrelide before the initiation of TKI therapy is allowed
- Ability to provide informed consent, as demonstrated by a clear understanding of the study's objectives and procedures and the ability to make an informed and voluntary decision to participate
- Signed written informed consent according to ICH/EU/GCP and national and local laws.
You will not qualify if you...
- Patients with advanced phases (accelerated or blastic phase) Ph+ and/or BCR-ABL+ CML
- Patients who experienced ED before TKI initiation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who undergo routine care with tyrosine kinase inhibitors for chronic myeloid leukemia are observed for the development of erectile dysfunction and cardiovascular events.
Visits at baseline, 6 months, 12 months, 18 months, and 24 months
Trial Site Locations
Total: 1 location
1
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, RE, Italy, 42121
Actively Recruiting
Research Team
I
Isabella Capodanno, MD
M
Maria Pina Faruolo
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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