Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life

Not Applicable

Not yet recruiting

• Conditions: Hypotestosteronism; Palliative Care
• Interventions: Drug: Sustanon 250

• Registration Number: NCT07143279
• Lead Sponsor: Jules Bordet Institute

Brief Summary

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 10 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 10 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1. Male hypogonadal with 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Testosterone supplementation in patients in best supportive care: impact on quality of life	Sustanon 250	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. Administration of Sustanon 250® (1 ml, IM) on day 0 after confirmation of hypogonadism by blood test and then every 10 days.

Primary Outcome Measures

Name	Time	Method
Quality of life assessed by ADL questionnaire	Every 10 days through study completion, an average of 1 month	-To assess the improvement in independence using the ADL independence scale (0, 1/2, 1) in terms of personal hygiene, dressing, going to the toilet, locomotion, continence and eating.

Secondary Outcome Measures

Name	Time	Method
EQ-5D-3L questionnaire	Every 10 days through study completion, an average of 1 month	To assess improvement of quality of life of subjects from the point of view of a family member or a proxy using the EQ-5D-3L questionnaire (EQ-5D-3L scale 0-100 where 0=worst outcome and 100=better outcome).