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

Sponsor

Lars Møller Pedersen (Other)

Overall Status

Completed

CT.gov ID

NCT04630275

Collaborator

(none)

172

Enrollment

Locations

13.4

Actual Duration (Months)

57.3

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism

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 8nmol/L 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.

Study Design

Study Type:

Observational

Actual Enrollment :

172 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Jan 12, 2022

Actual Study Completion Date :

Jan 12, 2022

Outcome Measures

Primary Outcome Measures

Serum-testosterone level [At inclusion]
The frequency of sexual dysfunction measured by serum-testosterone level below 8 nmol/L, in patients with DLBCL or HL.

Secondary Outcome Measures

Frequency of co-morbidity according to Cumulative Illness Rating Scale (CIRS) score [At inclusion]
The prevalence of CIRS score above 6
Frequency of Erectile Function according to International Index of Erectile Function (IIEF-5) [At inclusion]
The frequency of IIEF-5 scores below 22
Level of sexual dysfunction symptoms [At inclusion]
According to SHQ-22 symptom scores. High symptoms scores represents high level of symptoms.
Level of sexual function [At inclusion]
According to SHQ-22 function scores. High symptoms scores represents high level of functioning.
Level of Quality of life, functioning [At inclusion]
According to QLQ-C30 function scores. High function scores represents a high level of functioning.
Level of Quality of life, symptoms [At inclusion]
According to QLQ-C30 symptoms scores. High symptoms scores represents high level of symptoms.
Level of Quality of life, global health [At inclusion]
According to QLQ-C30 global health scores. High symptoms scores represents high level of global health.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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