Testosterone injections to improve quality of life for men in best supportive care.
Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life
This pilot will test whether giving Sustanon 250 testosterone injections every 15 days can improve quality of life for men with low testosterone who are receiving best supportive (palliative) care.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Jules Bordet Institute Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07143279 on ClinicalTrials.gov |
What this trial studies
This is a single-center, single-arm early-phase pilot enrolling adult men with documented hypogonadism (total testosterone < 231 ng/dL) who are receiving best supportive care and have no further therapeutic options. Participants will receive an intramuscular injection of Sustanon 250 (1 mL) on day 0 and then every 15 days, with quality of life measures tracked over the treatment period. Key exclusions include untreated prostate cancer and known hypersensitivity to the product or its excipients, including peanut or soya allergy. The study aims to collect preliminary safety and quality-of-life data to inform larger future trials.
Who should consider this trial
Good fit: Adult men (≥18 years) in best supportive care with documented low total testosterone (<231 ng/dL), who are able to consent and who have no further anti-cancer treatment planned and decline resuscitation.
Not a fit: Patients with untreated prostate cancer, known hypersensitivity to the drug or its excipients (including peanut or soya allergy), or those with extremely limited life expectancy who cannot complete treatment may not receive benefit.
Why it matters
Potential benefit: If successful, regular testosterone supplementation could reduce symptoms of low testosterone and improve overall well-being and quality of life for men in palliative supportive care.
How similar studies have performed: Testosterone replacement has improved symptoms in hypogonadal men in other clinical settings, but its specific use and benefits in patients receiving best supportive/palliative care are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Age ≥ 18 years old 3. 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: 1. Untreated prostate cancer, given the risk of epiduritis. 2. Known hypersensitivity reactions to the study drug or to any excipients. 3. Known allergies to peanuts or soya.
Where this trial is running
Brussels
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.