Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality-Obs
Condition: Hypogonadism
MeSH terms: Lymphoma; Hypogonadism; Gonadal Disorders
Study type: Observational

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. If serum testosterone is in the lower part of the normal reference interval, patients
      will be offered further hormonal evaluation by department of growth and reproduction at
      Copenhagen University Hospital. 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.
    

Detailed 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 age adjusted reference levels 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.

      To evaluate whether normal reference levels are sufficient in the examination of lymphoma
      survivors, included men with serum testosterone in the lower part of the normal reference
      interval will be offered further hormonal evaluation at the department of growth and
      reproduction at Copenhagen University hospital. Blood test results will be evaluted by this
      research group.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A cohort of patients with Hodgkin Lyphoma or Diffuse Large B-Cell Lymphoma diagnosed during
        the period April 2008- April 2018 at the Departments of Hematology, Herlev Hospital,
        Copenhagen University Hospital and Zealand University Hospital, will be identified through
        The Danish Lymphoma registry (LyFo).
      
Keywords: lymphoma; Diffuse Large B-Cell Lymphoma; Hodgkin; hypogonadism; testosterone; EORTC; Quality of life; Sexuality; Sexual health; Cancer; IIEF-5; Doxorubicin; anthracycline; Leydig cells; Hypothalamus; adriamycin