Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality
Condition: Hypogonadism
MeSH terms: Lymphoma; Hypogonadism; Gonadal Disorders
Study type: Interventional
Phase: Phase 2

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.
    

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 analysis of hormone levels or treatment of hypogonadism.
      With this study the aim is to investigate the effect and toxicity of treatment with exogenous
      testosterone in male long-term survivors of malignant lymphoma, to clarify whether it is
      relevant to include serum testosterone and potentially testosterone replacement therapy in
      standard follow-up programs.

      Our Hypothesis:

      Hypothesis 1: A significant proportion of long-term male survivors of HL and DLBCL have
      impaired quality of life (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.

      Hypothesis 4: Substitution with testosterone in carefully selected subgroups will improve
      sexual function and QoL.

      Hypothesis 5: Treatment with testosterone in this setting is safe with acceptable toxicity.

      To assess efficacy and safety of treatment with testosterone replacement therapy on
      hypogonadism in lymphoma patients, blood tests and questionnaires are completed throughout
      one year of treatment. To assess patient sexuality and quality of life, 3 questionnaires are
      included; the European Organisation for Research and Treatment of Cancer (EORTC) Quality of
      Life Questionnaire Core 30 (QLQ C30) for general quality of life, EORTC Sexual Health
      Questionnaire 22 (SHQ-22) for sexual health and International index of erectile function with
      5 questions (IIEF-5) for sexual function.
    

Intervention name(s): AndroGel
Intervention type(s): Drug
Intervention description(s): Treatment indication: hypogonadism after cancer treatment. Dosage: 1-2 sachets a day. Follows standard treatment.
Other intervention name(s): Testogel
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Intervention model description: Cured lymphoma patients who suffer from hypogonadism identified in a previous study, Vitality-Obs, will be treated with testosterone replacement therapy for the duration of one year. Patients are treated after standard indication and in standard doses. All will receive the same treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: quality of life; sexuality; sexual health; EORTC; QLQ-C30; SHQ-22; IIEF-5; hypogonadism; testosterone; cancer; lymphoma; diffuse large b-cell lymphoma; hodgkin