Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality-Obs

Hypogonadism Clinical Trial

Official title:

Vitality-Obs; An Observational and Descriptive Cross-sectional Study of Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630275
• Other study ID #: Vitality1
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: April 24, 2023

Study information

• Verified date: April 2023
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gonadal Disorders
• Hypogonadism
• Lymphoma

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital	Copenhagen
Denmark	Herlev University Hospital	Herlev
Denmark	Zealand University Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Lars Møller Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum-testosterone level	The frequency of sexual dysfunction measured by serum-testosterone level below age adjusted reference levels, in patients with DLBCL or HL.	At inclusion
Secondary	Frequency of co-morbidity according to Cumulative Illness Rating Scale (CIRS) score	The prevalence of CIRS score above 6	At inclusion
Secondary	Frequency of Erectile Function according to International Index of Erectile Function (IIEF-5)	The frequency of IIEF-5 scores below 22	At inclusion
Secondary	Level of sexual dysfunction symptoms	According to SHQ-22 symptom scores. High symptoms scores represents high level of symptoms.	At inclusion
Secondary	Level of sexual function	According to SHQ-22 function scores. High symptoms scores represents high level of functioning.	At inclusion
Secondary	Level of Quality of life, functioning	According to QLQ-C30 function scores. High function scores represents a high level of functioning.	At inclusion
Secondary	Level of Quality of life, symptoms	According to QLQ-C30 symptoms scores. High symptoms scores represents high level of symptoms.	At inclusion
Secondary	Level of Quality of life, global health	According to QLQ-C30 global health scores. High symptoms scores represents high level of global health.	At inclusion
Secondary	serum sex hormone binding globulin (SHBG)	The frequency of serum SHBG levels above the reference level	Through study completion, up to two years after incusion.
Secondary	Serum Luteinizing hormone (LH)	The frequency of serum LH levels above the reference level	Through study completion, up to two years after incusion.
Secondary	Serum Inhibin B	The frequency of serum Inhibin B levels below the reference level	Through study completion, up to two years after incusion.
Secondary	Serum Follicle stimulating hormone (FSH)	The frequency of serum FSH levels above the reference level	through study completion, up to two years after inclusion
Secondary	Serum Estradiol	The frequency of serum estradiol levels above the reference level	through study completion, up to two years after inclusion
Secondary	Serum INSL-3	The frequency of serum estradiol levels below the reference level	through study completion, up to two years after inclusion
Secondary	Serum hemoglobin	The frequency of serum hemoglobin levels above the reference level	through study completion, up to two years after inclusion
Secondary	Serum hematocrit	The frequency of serum hematocrit levels above the reference level	through study completion, up to two years after inclusion
Secondary	Serum free testosterone	The frequency of serum free testosterone levels above the reference level	through study completion, up to two years after inclusion