Testosterone replacement in young male cancer survivors

Phase 3

Completed

• Conditions: Testicular cancer, lymphoma or leukaemia and low testosterone level; Cancer; Testicular cancer, lymphoma or leukaemia

• Registration Number: ISRCTN70274195
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31714912 (added 15/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-19
• Study Completion: 2015-01-31
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 136

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Body composition, assessed after 26 weeks<br> 2. Participant self-reported physical function scores, assessed after 26 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. BMI, blood insulin, glucose, lipid levels and bone density, assessed after 26 weeks<br> 2. Participant self-reported quality of life, fatigue, self-esteem and sexual function scores, assessed after 26 weeks<br> 3. Participant self-reported quality of life, fatigue, self-esteem and sexual function scores, assessed after 39 weeks<br>