HypogonadismNCT04630275
Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality-Obs
An observational study of Hypogonadism, run by Lars Møller Pedersen at 3 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hypogonadism
- How many people
- 172 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Dec 2020to 24 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of patients with Hodgkin Lyphoma or Diffuse Large B-Cell Lymphoma diagnosed during the period April 2008- April 2018 at the Departments of Hematology, Herlev Hospital, Copenhagen University Hospital and Zealand University Hospital, will be identified through The Danish Lymphoma registry (LyFo).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Copenhagen University Hospital
Copenhagen, 2100
Herlev University Hospital
Herlev, 2730
Zealand University Hospital
Roskilde, 4000
About this study
Official title: Vitality-Obs; An Observational and Descriptive Cross-sectional Study of Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma
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.
Read the 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.
- Conditions
- Hypogonadism
- Keywords
- lymphoma, Diffuse Large B-Cell Lymphoma, Hodgkin, hypogonadism, testosterone, EORTC, Quality of life, Sexuality, Sexual health, Cancer, IIEF-5, Doxorubicin, anthracycline, Leydig cells, Hypothalamus, adriamycin
- Medical subject headings
- Hypogonadism, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Sexuality, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum-testosterone level
The frequency of sexual dysfunction measured by serum-testosterone level below age adjusted reference levels, in patients with DLBCL or HL.
Measured: At inclusion
Secondary outcomes (16)
Frequency of co-morbidity according to Cumulative Illness Rating Scale (CIRS) score
The prevalence of CIRS score above 6
Measured: At inclusion
Frequency of Erectile Function according to International Index of Erectile Function (IIEF-5)
The frequency of IIEF-5 scores below 22
Measured: At inclusion
Level of sexual dysfunction symptoms
According to SHQ-22 symptom scores. High symptoms scores represents high level of symptoms.
Measured: At inclusion
Level of sexual function
According to SHQ-22 function scores. High symptoms scores represents high level of functioning.
Measured: At inclusion
Level of Quality of life, functioning
According to QLQ-C30 function scores. High function scores represents a high level of functioning.
Measured: At inclusion
Level of Quality of life, symptoms
According to QLQ-C30 symptoms scores. High symptoms scores represents high level of symptoms.
Measured: At inclusion
Level of Quality of life, global health
According to QLQ-C30 global health scores. High symptoms scores represents high level of global health.
Measured: At inclusion
serum sex hormone binding globulin (SHBG)
The frequency of serum SHBG levels above the reference level
Measured: Through study completion, up to two years after incusion.
Serum Luteinizing hormone (LH)
The frequency of serum LH levels above the reference level
Measured: Through study completion, up to two years after incusion.
Serum Inhibin B
The frequency of serum Inhibin B levels below the reference level
Measured: Through study completion, up to two years after incusion.
Serum Follicle stimulating hormone (FSH)
The frequency of serum FSH levels above the reference level
Measured: through study completion, up to two years after inclusion
Serum Estradiol
The frequency of serum estradiol levels above the reference level
Measured: through study completion, up to two years after inclusion
Serum INSL-3
The frequency of serum estradiol levels below the reference level
Measured: through study completion, up to two years after inclusion
Serum hemoglobin
The frequency of serum hemoglobin levels above the reference level
Measured: through study completion, up to two years after inclusion
Serum hematocrit
The frequency of serum hematocrit levels above the reference level
Measured: through study completion, up to two years after inclusion
Serum free testosterone
The frequency of serum free testosterone levels above the reference level
Measured: through study completion, up to two years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Dec 2020
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Møller Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Møller Pedersen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630275
- Sponsor's protocol ID
- Vitality1
- Status last verified
- Apr 2023
- First submitted
- 27 Jul 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitality-Obs; An Observational and Descriptive Cross-sectional Study of Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT04630275
- Acronym / sponsor ID
- Vitality1
- Conditions
- Hypogonadism
- Keywords
- lymphoma, Diffuse Large B-Cell Lymphoma, Hodgkin, hypogonadism, testosterone, EORTC, Quality of life, Sexuality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Lars Møller PedersenUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of patients with Hodgkin Lyphoma or Diffuse Large B-Cell Lymphoma diagnosed during the period April 2008- April 2018 at the Departments of Hematology, Herlev Hospital, Copenhagen University Hospital and Zealand University Hospital, will be identified through The Danish Lymphoma registry (LyFo).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum-testosterone level
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.
16 secondary outcomes
Frequency of co-morbidity according to Cumulative Illness Rating Scale (CIRS) score
Time frame: At inclusion
Frequency of Erectile Function according to International Index of Erectile Function (IIEF-5)
Time frame: At inclusion
Level of sexual dysfunction symptoms
Time frame: At inclusion
Level of sexual function
Time frame: At inclusion
Level of Quality of life, functioning
Time frame: At inclusion
Level of Quality of life, symptoms
Time frame: At inclusion
Level of Quality of life, global health
Time frame: At inclusion
serum sex hormone binding globulin (SHBG)
Time frame: Through study completion, up to two years after incusion.
Serum Luteinizing hormone (LH)
Time frame: Through study completion, up to two years after incusion.
Serum Inhibin B
Time frame: Through study completion, up to two years after incusion.
Serum Follicle stimulating hormone (FSH)
Time frame: through study completion, up to two years after inclusion
Serum Estradiol
Time frame: through study completion, up to two years after inclusion
Serum INSL-3
Time frame: through study completion, up to two years after inclusion
Serum hemoglobin
Time frame: through study completion, up to two years after inclusion
Serum hematocrit
Time frame: through study completion, up to two years after inclusion
Serum free testosterone
Time frame: through study completion, up to two years after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism, run by Lars Møller Pedersen at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum-testosterone level (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.