Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorJules Bordet Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Sustanon 250
DrugSustanon 250® (1 ml, IM) every 10 days
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Testosterone supplementation in patients in best supportive care: impact on quality of lifeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quality of life assessed by ADL questionnaire
Best improvement over time in independence using the ADL independence scale in terms of personal hygiene, dressing, going to the toilet, locomotion, continence and eating. The primary endpoint is defined as the difference between the best score after baseline and the initial score at baseline.
Time frame
Every 15 days through study completion2
Quality of life assessed by Edmonton Symptom Assessment Scale
Best improvement over time in symptoms of pain, fatigue, sadness, anxiety, drowsiness, appetite, sense of well-being, shortness of breath, bowel movements and strength using the Edmonton Symptom Assessment Scale. The primary endpoint is defined as the difference between the best score after baseline and the initial score at baseline.
Time frame
Every 15 days through study completion,Secondary outcomes
1
EQ-5D-3L questionnaire
Improvement of quality of life of subjects from the point of view of a proxy using the EQ-5D-3L questionnaire (EQ-5D-3L scale 0-100 where 0=worst outcome and 100=better outcome)
Time frame
Every 15 days through study completion2
Dynamic/change of the ADL and Edmonton System Assessment Scale during treatment
The average of ADL and Edmonton Symptom Assessment Scale during treatment after baseline.
Time frame
At each time point during treatment, especially at Day 15.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov