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

NCT ID: NCT04492553

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-11-10

Brief Summary

This study is a prospective non-randomised open label multicenter phase two study in male long-term survivors of malignant lymphoma including Hodgkin Lymphoma (HL) and Diffuse Large B-Cell Lymphoma (DLBCL). The study aims to assess whether low levels of testosterone in the blood of patients cured for aggressive lymphoma, can be effectively treated with Testosterone gel, and if treatment with testosterone can improve their general quality of life. The investigators hypothesize that patients will develop sexual dysfunction and poor quality of life when suffering from untreated 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 three questionnaires, and serum testosterone level, during one year of treatment with Testogel. The intention is to show that future follow-up visits should include focus on sexuality and serum testosterone, so relevant patients can be identified and treated for their hormonedeficiency without delay. The expected follow-up program include questionnaires and blood samples, which are easily implemented 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 analysis of hormone levels or treatment of hypogonadism. With this study the aim is to investigate the effect and toxicity of treatment with exogenous testosterone in male long-term survivors of malignant lymphoma, to clarify whether it is relevant to include serum testosterone and potentially testosterone replacement therapy in standard follow-up programs.

Our Hypothesis:

Hypothesis 1: A significant proportion of long-term male survivors of HL and DLBCL have impaired quality of life (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.

Hypothesis 4: Substitution with testosterone in carefully selected subgroups will improve sexual function and QoL.

Hypothesis 5: Treatment with testosterone in this setting is safe with acceptable toxicity.

To assess efficacy and safety of treatment with testosterone replacement therapy on hypogonadism in lymphoma patients, blood tests and questionnaires are completed throughout one year of treatment. To assess patient sexuality and quality of life, 3 questionnaires are included; the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ C30) for general quality of life, EORTC Sexual Health Questionnaire 22 (SHQ-22) for sexual health and International index of erectile function with 5 questions (IIEF-5) for sexual function.

Conditions

Hypogonadism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Testogel

All patients will be treated with Testogel. Starting dose is 1 sachet of gel daily applied to the skin of arms, thighs or abdomen. Dose adjustments are made after serum-levels of testosterone. All patients will be treated for a total of 52 weeks, unless they exit the study early because of side-effects or other reasons.

Group Type: EXPERIMENTAL

AndroGel

Intervention Type: DRUG

Treatment indication: hypogonadism after cancer treatment. Dosage: 1-2 sachets a day. Follows standard treatment.

Interventions

AndroGel

Treatment indication: hypogonadism after cancer treatment. Dosage: 1-2 sachets a day. Follows standard treatment.

Intervention Type: DRUG

Other Intervention Names

Testogel

Eligibility Criteria

Inclusion Criteria

1. Age 18-65 years at inclusion

2. Male

3. Verified diagnosis of de novo DLBCL or classical HL diagnosed between April 2008 and April 2018 according to World Health Organization (WHO) classification.

4. Completed curative intent first line treatment with anthracycline-containing chemotherapy with or without consolidating radiotherapy, with disease in complete remission at End of Treatment (EOT) Positron Emissions Tomography / Computerized Tomography (PET/CT) at least one year prior to inclusion.

5. Literate in Danish

6. Serum testosterone level below threshold for age adjusted reference level used in the local laboratory at the time of inclusion.

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. Contraindications for the treatment with testosterone: Verified prostate cancer / Prostate Specific Antigen (PSA) > 3 ng/ml, cancer of the mammae, primary liver cancer or polycythaemia vera / Hct > 0,49.

5. Mental or physical conditions that are expected to prevent the necessary "compliance" and/or "adherence" in relation to the study procedures

6. Current or prior anabolic steroid drug abuse

7. Treatment with second line chemotherapy or high dose therapy.

8. Known allergies to additives in Testogel.

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

Sponsors

Besins Healthcare

INDUSTRY

Sponsor Role: collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Lars Møller Pedersen

OTHER

Sponsor Role: lead

Responsible Party

Lars Møller Pedersen

Senior consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lars Møller Pedersen, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

Copenhagen University Hospital

Copenhagen, , Denmark

Herlev University Hospital

Herlev, , Denmark

Zealand University Hospital

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

Vitality

Identifier Type: -

Identifier Source: org_study_id