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

NCT04492553 | Completed Phase 2 DMC

• 1 other identifier: Vitality
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypogonadism

Keywords

quality of life; sexuality; sexual health; EORTC; QLQ-C30; SHQ-22; IIEF-5; hypogonadism; testosterone; cancer; lymphoma; diffuse large b-cell lymphoma; hodgkin

Outcome Measures

Primary Outcomes (1)

• Effect of testosterone on QLQ C-30 score

  Effect of treatment with testosterone on QLQ C30 score from baseline to end of study (12 months after inclusion). Scores a measured from 3 scales; function, symptoms and global health. Highest score is 100. Scoring after an algorithm.

  1 year

Secondary Outcomes (5)

• Effect of testosterone on QLQ SHQ-22 score

  1 year

• Effect of testosterone on IIEF-5 score

  1 year

• Time from baseline until significant change in questionnaire scores are seen

  1 year

• S-testosteron change

  1 year

• Testosterone dose needed for significant change in scores

  1 year

Study Arms (1)

Testogel

EXPERIMENTAL

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.

Drug: AndroGel

Interventions

AndroGel DRUG

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

Also known as: Testogel

Testogel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Gender is based on social security number
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Concurrent low-grade lymphoma
• Current or prior lymphoproliferative disease of the central nervous system (CNS)
• Current or prior lymphoproliferative disease of the testes
• 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.
• Mental or physical conditions that are expected to prevent the necessary "compliance" and/or "adherence" in relation to the study procedures
• Current or prior anabolic steroid drug abuse
• Treatment with second line chemotherapy or high dose therapy.
• Known allergies to additives in Testogel.

Sponsors & Collaborators

• Lars Møller Pedersen: lead
• Besins Healthcare: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Zealand University Hospital: collaborator

Study Sites (3)

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Herlev University Hospital

Herlev, 2730, Denmark

Location

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Hypogonadism; Sexuality; Neoplasms; Lymphoma; Lymphoma, Large B-Cell, Diffuse

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Sexual Behavior; Behavior; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Lars Møller Pedersen, MD

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior consultant

Model Details: Cured lymphoma patients who suffer from hypogonadism identified in a previous study, Vitality-Obs, will be treated with testosterone replacement therapy for the duration of one year. Patients are treated after standard indication and in standard doses. All will receive the same treatment.

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: April 1, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

DK (3)