Testicular cancer, lymphoma or leukaemia and low testosterone level Cancer Testicular cancer, lymphoma or leukaemia
Conditions
Interventions
Patients are randomised to receive either the Tostran® 2% (testosterone) gel or placebo gel. There is a 26-week double-blinded treatment phase followed by a 13-week open-label active treatment phase f
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Able and willing to comply with all study procedures 2. Able to provide written informed consent 3. Male, aged between 25 and 50 years 4. Post-pubertal 5. Previous testicular cancer, lymphoma or leukaemia 6. At least 12 months from completion of curative treatment for testicular cancer, lymphoma or leukaemia 7. A serum testosterone level =7 nmol/l and =12 nmol/l 8. Taking any hormone replacement, on stable doses for the last 6 months
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) of more than 35 kg/m2 2. Currently receiving corticosteroid therapy or likely to receive corticosteroids during the trial 3. Previous testosterone treatment within 12 months of entering the trial 4. Previous allogeneic bone marrow transplant 5. A history of hormone-dependent cancer (e.g., prostate or breast cancer) 6. A history of primary liver tumour 7. Hypercalcaemia 8. Nephrotic syndrome 9. Diabetes 10. Other severe concurrent disease or mental disorders which would affect the collection of study measurements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body composition, assessed after 26 weeks 2. Participant self-reported physical function scores, assessed after 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. BMI, blood insulin, glucose, lipid levels and bone density, assessed after 26 weeks 2. Participant self-reported quality of life, fatigue, self-esteem and sexual function scores, assessed after 26 weeks 3. Participant self-reported quality of life, fatigue, self-esteem and sexual function scores, assessed after 39 weeks | — |
Countries
United Kingdom
Outcome results
None listed