Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-54
SponsorSeattle Institute for Biomedical and Clinical Research
About this trial
The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cancer survivors who have received chemotherapy and/or radiation therapy for their cancer and are now in remission for at least one year
Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias
Age: 18-54 years
Serum testosterone, measured by mass spectrometry (gold standard method), of <348 ng/dl and/or free testosterone <70 pg/ml. The lower limits of the normal range for total testosterone in healthy young men (age 19-40 years), is 348 ng/dL and the lower limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample97. Therefore, young symptomatic men with total testosterone <348 ng/dl could be considered testosterone deficient. As sex hormone binding globulin levels may be elevated in some men with cancer (resulting in elevation in total testosterone level), some of these symptomatic men may still be hypogonadal despite having total testosterone above this cut-off limit. However; their free testosterone levels may still be below the lower limit of normal. Thus, we will also include men with free testosterone <70 pg/mL.
Disqualifiers
Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown origin)
Men with brain cancer (potential cognitive impairment)
Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months
Appetite stimulating agents e.g. megestrol acetate within the past 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]
Drugfirst two doses four weeks apart; following three more doses every ten weeks.
placebo
Other interventionfirst two doses four weeks apart; following three more doses every ten weeks.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: TestosteroneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fatigue change
(Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) questionnaire
Time frame
9 monthsSecondary outcomes
1
Sexual function change
Harbor-UCLA 7-day Sexual Function Questionnaire
Time frame
9 months2
Sexual function change
International Index of Erective Function (IIEF) questionnaire
Time frame
9 months3
Body composition change
Lean body mass and fat mass (kg) measured by dual energy x-ray absorptiometry (DEXA)
Time frame
9 months4
Changes to mood and well-being
Mood and well-being will be assessed by the Positive and Negative Affect Scale (PANAS) affectivity balance scale, which includes 10 questions each for Positive Affect and Negative Affect. Many behavioral scientists consider affectivity as the cleanest window on an individual's wellbeing. The most sensitive indicator of impaired wellbeing has been shown to be affective dysregulation, which is reflected in affectivity balance. The latter incorporates negative affects (e.g., anxiety, depression) as well as positive affects (e.g., joy).
Time frame
9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov