Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality
NCT04492553
Behavior, Endocrine System Diseases
Copenhagen, Denmark
View Trial DetailsNCT Number: NCT04630275
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.
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Notify Me18 year–65 year
Male
Observational
Copenhagen University Hospital, Copenhagen, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At inclusion
The frequency of sexual dysfunction measured by serum-testosterone level below age adjusted reference levels, in patients with DLBCL or HL.
Time frame: At inclusion
The prevalence of CIRS score above 6
Time frame: At inclusion
The frequency of IIEF-5 scores below 22
Time frame: At inclusion
According to SHQ-22 symptom scores. High symptoms scores represents high level of symptoms.
Time frame: At inclusion
According to SHQ-22 function scores. High symptoms scores represents high level of functioning.
Time frame: At inclusion
According to QLQ-C30 function scores. High function scores represents a high level of functioning.
Time frame: At inclusion
According to QLQ-C30 symptoms scores. High symptoms scores represents high level of symptoms.
Time frame: At inclusion
According to QLQ-C30 global health scores. High symptoms scores represents high level of global health.
Time frame: Through study completion, up to two years after incusion.
The frequency of serum SHBG levels above the reference level
Time frame: Through study completion, up to two years after incusion.
The frequency of serum LH levels above the reference level
Time frame: Through study completion, up to two years after incusion.
The frequency of serum Inhibin B levels below the reference level
Time frame: through study completion, up to two years after inclusion
The frequency of serum FSH levels above the reference level
Time frame: through study completion, up to two years after inclusion
The frequency of serum estradiol levels above the reference level
Time frame: through study completion, up to two years after inclusion
The frequency of serum estradiol levels below the reference level
Time frame: through study completion, up to two years after inclusion
The frequency of serum hemoglobin levels above the reference level
Time frame: through study completion, up to two years after inclusion
The frequency of serum hematocrit levels above the reference level
Time frame: through study completion, up to two years after inclusion
The frequency of serum free testosterone levels above the reference level
Lars Møller Pedersen
Other
Vitality-Obs; An Observational and Descriptive Cross-sectional Study of Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma
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