Recruiting

Study of testosterone supplementation to improve quality of life in male patients receiving palliative care who have androgen deficiency

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying testosterone supplementation in male patients receiving supportive care who have androgen deficiency. The study will use Sustanon 250, which is an injectable solution containing four different forms of testosterone: testosterone decanoate, testosterone isocaproate, testosterone phenylpropionate, and testosterone propionate. The purpose is to evaluate how testosterone supplementation affects quality of life in patients who are receiving supportive care.

The study will examine how testosterone treatment influences daily activities and various symptoms that patients may experience. These activities include personal care tasks, while the symptoms being monitored include physical conditions such as fatigue, pain, and breathing difficulties, as well as emotional well-being. The medication will be given through intravenous administration, and patients will be monitored over time to assess any improvements in their overall condition and independence in daily activities.

During the study, healthcare providers will regularly assess patients' ability to perform everyday tasks and their general well-being. The assessment will include monitoring how well patients can take care of themselves and how they feel in terms of various physical and emotional symptoms. The study will also consider feedback from people close to the patients about changes in their quality of life.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Assessment
Your total testosterone level will be measured to confirm it is below 231 ng/dl
You will complete two questionnaires: the ADL independence scale (measuring daily activities like hygiene, dressing, and mobility) and the Edmonton Symptom Assessment Scale (measuring symptoms like pain, fatigue, and well-being)
A person close to you will complete a quality of life questionnaire called EQ-5D-3L
Step 2
Treatment Start
You will receive Sustanon 250, a combination of four testosterone medications
The medication will be given through an intravenous injection
The treatment contains: testosterone decanoate, testosterone isocaproate, testosterone phenylpropionate, and testosterone propionate
Step 3
Follow-up Assessment - Day 15
You will complete the same questionnaires as in the initial assessment
Your symptoms and daily activities will be evaluated
The person close to you will complete another quality of life assessment
Step 4
Ongoing Monitoring
Regular assessments will continue throughout the treatment period
The same questionnaires will be used to track changes in your daily activities and symptoms
The study will continue until August 2026

Who can join the trial?

7 criteria

Must be a male patient with low testosterone levels (specifically below 231 ng/dl) who is receiving supportive care and has no other treatment options available
Must be 18 years of age or older
Must be able to fully understand the study information provided and be capable of signing the consent form before participating in any study procedures
Must have a condition known as hypogonadism (a medical term for low testosterone production) along with cancer
Must be receiving best supportive care (medical care focused on comfort and quality of life rather than treating the disease)
Must have made a decision not to receive resuscitation measures
Must be able to make informed decisions about their medical care

Who cannot join the trial?

8 criteria

Patients who are not male (females cannot participate)
Patients who are not adults (only adult males can participate)
Patients who still have available therapeutic treatment options
Patients who wish to receive reanimation (life-saving) procedures
Patients who do not require palliative care (care focused on providing relief from symptoms and stress of serious illness)
Patients who do not have androgen deficiency (low levels of male hormones, particularly testosterone)
Patients who are not willing to receive testosterone supplementation therapy
Patients who are part of vulnerable populations (such as prisoners, mentally disabled persons, or other protected groups)

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Investigated drugs

Testosterone
is a hormone that plays a crucial role in male physical characteristics and overall well-being. As a supplementation therapy, it helps increase testosterone levels in the body. This treatment aims to improve quality of life in male patients receiving supportive care. Testosterone supplementation can help with energy levels, mood, muscle strength, and overall physical function.
Best Supportive Care
refers to a treatment approach that focuses on improving a patient's comfort and quality of life. It includes managing symptoms and providing comprehensive care to support the patient's physical and emotional needs, without attempting aggressive medical interventions.

What is already known about the treatment

Testosterone - A naturally occurring hormone and medication administered through injections, gels, patches, or oral forms, primarily used in hormone replacement therapy for men with testosterone deficiency (hypogonadism) and in palliative care settings. This steroid hormone belongs to the androgen class of medications and works by binding to androgen receptors throughout the body, promoting the development and maintenance of male sexual characteristics, muscle mass, bone density, and overall well-being. In clinical practice, testosterone supplementation is carefully monitored to maintain appropriate hormone levels while managing potential side effects, with various formulations available to suit individual patient needs and treatment goals.

Investigated diseases

Androgen Deficiency
A condition where the body doesn't produce enough male hormones, particularly testosterone. This condition can develop gradually and affects various body functions. Men with androgen deficiency may experience decreased muscle mass, reduced bone density, and changes in body fat distribution. The condition can affect energy levels, physical strength, and overall body composition. It may occur naturally with aging or develop due to various underlying health conditions.
Palliative Condition
A progressive state requiring supportive care when a person has a serious illness. This condition involves multiple symptoms that can affect daily activities and quality of life. The person may experience varying levels of physical capability and independence in performing everyday tasks. It typically involves managing multiple symptoms that can change over time. The condition affects various aspects of daily living, including mobility, self-care, and general well-being.