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

NCT ID: NCT04630275

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-04-24

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. 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.

Conditions

Hypogonadism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lars Møller Pedersen

OTHER

Sponsor Role: lead

Responsible Party

Lars Møller Pedersen

Senior Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Copenhagen University Hospital

Copenhagen, , Denmark

Herlev University Hospital

Herlev, , Denmark

Zealand University Hospital

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

Vitality1

Identifier Type: -

Identifier Source: org_study_id