- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04630275
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Copenhagen University Hospital
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Herlev, Denmark, 2730
- Herlev University Hospital
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Roskilde, Denmark, 4000
- Zealand University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18-65 years at follow-up
- Male
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum-testosterone level
Time Frame: At inclusion
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The frequency of sexual dysfunction measured by serum-testosterone level below age adjusted reference levels, in patients with DLBCL or HL.
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At inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of co-morbidity according to Cumulative Illness Rating Scale (CIRS) score
Time Frame: At inclusion
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The prevalence of CIRS score above 6
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At inclusion
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Frequency of Erectile Function according to International Index of Erectile Function (IIEF-5)
Time Frame: At inclusion
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The frequency of IIEF-5 scores below 22
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At inclusion
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Level of sexual dysfunction symptoms
Time Frame: At inclusion
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According to SHQ-22 symptom scores.
High symptoms scores represents high level of symptoms.
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At inclusion
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Level of sexual function
Time Frame: At inclusion
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According to SHQ-22 function scores.
High symptoms scores represents high level of functioning.
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At inclusion
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Level of Quality of life, functioning
Time Frame: At inclusion
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According to QLQ-C30 function scores.
High function scores represents a high level of functioning.
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At inclusion
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Level of Quality of life, symptoms
Time Frame: At inclusion
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According to QLQ-C30 symptoms scores.
High symptoms scores represents high level of symptoms.
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At inclusion
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Level of Quality of life, global health
Time Frame: At inclusion
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According to QLQ-C30 global health scores.
High symptoms scores represents high level of global health.
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At inclusion
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serum sex hormone binding globulin (SHBG)
Time Frame: Through study completion, up to two years after incusion.
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The frequency of serum SHBG levels above the reference level
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Through study completion, up to two years after incusion.
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Serum Luteinizing hormone (LH)
Time Frame: Through study completion, up to two years after incusion.
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The frequency of serum LH levels above the reference level
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Through study completion, up to two years after incusion.
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Serum Inhibin B
Time Frame: Through study completion, up to two years after incusion.
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The frequency of serum Inhibin B levels below the reference level
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Through study completion, up to two years after incusion.
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Serum Follicle stimulating hormone (FSH)
Time Frame: through study completion, up to two years after inclusion
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The frequency of serum FSH levels above the reference level
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through study completion, up to two years after inclusion
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Serum Estradiol
Time Frame: through study completion, up to two years after inclusion
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The frequency of serum estradiol levels above the reference level
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through study completion, up to two years after inclusion
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Serum INSL-3
Time Frame: through study completion, up to two years after inclusion
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The frequency of serum estradiol levels below the reference level
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through study completion, up to two years after inclusion
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Serum hemoglobin
Time Frame: through study completion, up to two years after inclusion
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The frequency of serum hemoglobin levels above the reference level
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through study completion, up to two years after inclusion
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Serum hematocrit
Time Frame: through study completion, up to two years after inclusion
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The frequency of serum hematocrit levels above the reference level
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through study completion, up to two years after inclusion
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Serum free testosterone
Time Frame: through study completion, up to two years after inclusion
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The frequency of serum free testosterone levels above the reference level
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through study completion, up to two years after inclusion
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vitality1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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