Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
This study is a prospective non-randomised open label multicenter phase two study in male
long-term survivors of malignant lymphoma including Hodgkin Lymphoma (HL) and Diffuse Large
B-Cell Lymphoma (DLBCL). The study aims to assess whether low levels of testosterone in the
blood of patients cured for aggressive lymphoma, can be effectively treated with Testosterone
gel, and if treatment with testosterone can improve their general quality of life. The
investigators hypothesize that patients will develop sexual dysfunction and poor quality of
life when suffering from untreated reduced level of testosterone.
Cancer treatment is increasingly effective and the overall survival higher, which makes
issues like sexuality and long-term quality of life more and more important to address in
cured cancer patients. Patient sexuality and quality of life is measured by three
questionnaires, and serum testosterone level, during one year of treatment with Testogel. The
intention is to show that future follow-up visits should include focus on sexuality and serum
testosterone, so relevant patients can be identified and treated for their hormonedeficiency
without delay. The expected follow-up program include questionnaires and blood samples, which
are easily implemented and without great cost.
Phase:
Phase 2
Details
Lead Sponsor:
Lars Møller Pedersen
Collaborators:
Besins Healthcare Copenhagen University Hospital at Herlev Zealand University Hospital