Clinical trial · Observational
Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality-Obs
Vitality-Obs; An Observational and Descriptive Cross-sectional Study of Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypogonadism | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Serum-testosterone level
- timeFrame
- At inclusion
- description
- The frequency of sexual dysfunction measured by serum-testosterone level below age adjusted reference levels, in patients with DLBCL or HL.
Secondary outcomes (16)
- measure
- Frequency of co-morbidity according to Cumulative Illness Rating Scale (CIRS) score
- timeFrame
- At inclusion
- description
- The prevalence of CIRS score above 6
- measure
- Frequency of Erectile Function according to International Index of Erectile Function (IIEF-5)
- timeFrame
- At inclusion
- description
- The frequency of IIEF-5 scores below 22
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-65 years at follow-up 2. Male 3. Verified diagnosis of de novo DLBCL or classical HL diagnosed between April 2008 and April 2018 according to WHO classification. 4. 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. 5. Literate in Danish Exclusion Criteria: 1. Concurrent low-grade lymphoma 2. Current or prior lymphoproliferative disease of the central nervous system (CNS) 3. Current or prior lymphoproliferative disease of the testes 4. Mental or physical conditions that are expected to prevent the necessary "compliance" and/or "adherence" in relation to the study procedures. 5. Treatment with second line chemotherapy or high dose therapy. 6. Current or prior anabolic steroid drug abuse
References
Publications (0)
Data not yet available