Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality (Vitality)
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|ClinicalTrials.gov Identifier: NCT04492553|
Recruitment Status : Not yet recruiting
First Posted : July 30, 2020
Last Update Posted : August 3, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: AndroGel||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; A Prospective Non Randomised Open Label Multicenter Phase Two Study in Male Longterm Survivors of Malignant Lymphoma (Vitality)|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||June 2022|
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.
Treatment indication: hypogonadism after cancer treatment. Dosage: 1-2 sachets a day. Follows standard treatment.
Other Name: Testogel
- Effect of testosterone on QLQ C-30 score [ Time Frame: 1 year ]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.
- Effect of testosterone on QLQ SHQ-22 score [ Time Frame: 1 year ]Effect of treatment with testosterone on QLQ SHQ-22 score from baseline to end of study (12 months after inclusion). Scores a measured from 2 scales; function and symptoms. Highest score is 100. Scoring after an algorithm.
- Effect of testosterone on IIEF-5 score [ Time Frame: 1 year ]Effect of treatment with testosterone on symptoms of hypogonadism (IIEF-5 score) from baseline to end of study (12 months after inclusion). IIEF-5 is based on 5 questions. Scores range from 5 to 25, Lower scores mean higher degree of erectile dysfunction.
- Time from baseline until significant change in questionnaire scores are seen [ Time Frame: 1 year ]Time from baseline to a significant decrease in QLQ C30, QLQ SHQ-22 (a little change 5-10 points difference, moderate change 10-20, very much change above 20) and IIEF-5 (changing from at least one category to the next) score is seen.
- S-testosteron change [ Time Frame: 1 year ]S-testosterone from baseline to end of study (12 months after inclusion).
- Testosterone dose needed for significant change in scores [ Time Frame: 1 year ]Testosterone dose needed before significant decrease in QLQ C30, QLQ SHQ-22 and IIEF-5 score. Dosing range from 1 to 2 sachets of Testogel per day.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492553
|Contact: Signe Micas Pedersenfirstname.lastname@example.org|
|Contact: Lars Møller Pedersenemail@example.com|
|Copenhagen University Hospital|
|Copenhagen, Denmark, 2100|
|Herlev University Hospital|
|Herlev, Denmark, 2730|
|Zealand University Hospital|
|Roskilde, Denmark, 4000|
|Principal Investigator:||Lars Møller Pedersen||Herlev Hospital|