Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality-Obs

  • STATUS
    Recruiting
  • days left to enroll
    42
  • participants needed
    600
  • sponsor
    Lars Møller Pedersen
Updated on 21 February 2021

Summary

This study is an observational cross-sectional study which aims to investigate the relationship between treatment with chemotherapy and the development of low levels of testosterone in the blood in patients cured for aggressive lymphoma. We hypothesize that patients in turn will develop sexual dysfunction and poor quality of life because of this 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 3 questionnaires filled out once, and serum testosterone by a single blood sample. We hope to show that future follow up visits should include focus on sexuality and serum testosterone. Questionnaires and blood samples can be implemented easily and without great cost.

Description

Diffuse large B-cell lymphoma and Hodgkin Lymphoma are two aggressive lymphomas often treated with doxorubicin containing chemotherapy. Doxorubicin is an anthracycline and is known to be toxic to both Leydig Cells of the testes and hormone-producing cells of the hypothalamus. Therefore patients treated with this drug are at risk of developing hypogonadism. Standard follow-up programs do not include investigation of hormone levels. With this study we aim to investigate the extent of hypogonadisme in patients treated with anthracycline containing chemotherapy, to clarify whether it is relevant to include serum testosterone in standard follow-up programs.

Our Hypothesis:

Hypothesis 1: A significant proportion of long-term male survivors of HL and DLBCL have impaired QoL due to sexual dysfunction.

Hypothesis 2: A significant proportion of long-term male survivors of HL and DLBCL have reduced levels of testosterone.

Hypothesis 3: A significant relationship between QoL, sexual dysfunction and testosterone levels exists.

To clarify the extent of hypogonadisme a single blood test including s-total-testosterone will be drawn once, and levels below 8nmol/L will be classified as hypogonadisme. To assess patients sexuality and quality of life, 3 questionnaires will be filled out; the EORTC QLQ-C30 for general quality of life, EORTC SHQ-22 for sexual health and IIEF-5 for sexual function.

Details
Condition Hypogonadism
Clinical Study IdentifierNCT04630275
SponsorLars Møller Pedersen
Last Modified on21 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Are you male?
Do you have any of these conditions: Do you have Hypogonadism??
Age 18-65 years at follow-up
Male
Verified diagnosis of de novo DLBCL or classical HL diagnosed between April 2013 and April 2018 according to WHO classification
Completed curative intent first line treatment with anthracycline-containing chemotherapy with or without consolidating radiotherapy, with disease in complete remission at EOT-PET/CT at least one year prior to inclusion
Literate in Danish

Exclusion Criteria

Concurrent low-grade lymphoma
Current or prior lymphoproliferative disease of the central nervous system (CNS)
Current or prior lymphoproliferative disease of the testes
Mental or physical conditions that are expected to prevent the necessary "compliance" and/or "adherence" in relation to the study procedures
Treatment with second line chemotherapy or high dose therapy
Current or prior anabolic steroid drug abuse
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