Vitality-Obs; An Observational and Descriptive Cross-sectional Study of Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 3
- 主要终点
- Serum-testosterone level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years at follow-up
- •Verified diagnosis of de novo DLBCL or classical HL diagnosed between April 2008 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
排除标准
- •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
结局指标
主要结局
Serum-testosterone level
时间窗: At inclusion
The frequency of sexual dysfunction measured by serum-testosterone level below age adjusted reference levels, in patients with DLBCL or HL.
次要结局
- Frequency of co-morbidity according to Cumulative Illness Rating Scale (CIRS) score(At inclusion)
- Frequency of Erectile Function according to International Index of Erectile Function (IIEF-5)(At inclusion)
- Level of Quality of life, symptoms(At inclusion)
- Level of Quality of life, global health(At inclusion)
- Serum Luteinizing hormone (LH)(Through study completion, up to two years after incusion.)
- Serum Inhibin B(Through study completion, up to two years after incusion.)
- Serum Follicle stimulating hormone (FSH)(through study completion, up to two years after inclusion)
- Serum hemoglobin(through study completion, up to two years after inclusion)
- Serum hematocrit(through study completion, up to two years after inclusion)
- Serum free testosterone(through study completion, up to two years after inclusion)
- Level of sexual function(At inclusion)
- Level of Quality of life, functioning(At inclusion)
- Level of sexual dysfunction symptoms(At inclusion)
- serum sex hormone binding globulin (SHBG)(Through study completion, up to two years after incusion.)
- Serum Estradiol(through study completion, up to two years after inclusion)
- Serum INSL-3(through study completion, up to two years after inclusion)
研究者
Lars Møller Pedersen
Senior Consultant
Herlev Hospital