Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sustanon 250.
- Who it may be relevant to
- Registry conditions: Hypotestosteronism, Palliative Care. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a monocentric, single-arm prospective pilot study that will enrol hypogonadal (testosterone \< 231 ng/dL) male subjects in best supportive care, with no further therapeutic options and no need for resuscitation. Currently, testosterone formulations for intramuscular (IM) injection and subcutaneous injection as well as for oral and transdermal administration have been approved for androgen therapy. To date, injectable testosterone is the most commonly used formulation. To increase serum testosterone levels to the physiological range IM injections of testosterone every 2-3 weeks are required, which lead to supraphysiological peaks shortly after administration, followed by a sharp fall in levels thereafter. Testosterone levels before the next injection are frequently in the hypogonadal range. For this reason, Sustanon 250® (1 ml, IM) will be administered on day 0 after confirmation of hypogonadism by blood test and then every 15 days in this trial given the limited life expectancy of the subjects and to maximise the effect and benefit of testosterone supplementation. The Edmonton questionnaire and ADL questionnaire will be completed before the injection on day 0 and then every 15 days at the time of injection until subject's death or if a subject is discontinued from the study treatment/procedures for any other reasons than death. In parallel, the EQ-5D-3L questionnaire will be completed by a family member or a proxy.
Interventions
- Drug Sustanon 250
Sustanon 250® (1 ml, IM) every 10 days
Primary outcome measures
- Quality of life assessed by ADL questionnaire [Time frame: Every 15 days through study completion]
- Quality of life assessed by Edmonton Symptom Assessment Scale [Time frame: Every 15 days through study completion,]
Secondary outcome measures (2)
- EQ-5D-3L questionnaire [Time frame: Every 15 days through study completion]
- Dynamic/change of the ADL and Edmonton System Assessment Scale during treatment [Time frame: At each time point during treatment, especially at Day 15.]
Eligibility criteria
Inclusion criteria
- Male hypogonadal with total testosterone < 231 ng/dl in best supportive care with no further therapeutic options and who do not wish to be reanimated.
- Age ≥ 18 years old
- Patient able to understand the patient information sheet and able to sign the Informed Consent form (ICF) prior to any study related procedure.
Exclusion criteria
- Untreated prostate cancer, given the risk of epiduritis.
- Known hypersensitivity reactions to the study drug or to any excipients.
- Known allergies to peanuts or soya.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Institut Jules Bordet — Brussels
Identifiers
NCT: NCT07143279 · IJB-SP01-2025 · 2025-522023-10-00