Testosterone replacement in young male cancer survivors
| ISRCTN | ISRCTN70274195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70274195 |
| Secondary identifying numbers | STH15216 |
- Submission date
- 04/02/2011
- Registration date
- 19/05/2011
- Last edited
- 15/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Jayne Swain
Scientific
Scientific
Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom
Study information
| Study design | Prospective multicentre randomised double-blinded parallel-group placebo-controlled phase III superiority clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Testosterone Replacement in Young Male cancer Survivors: a prospective, multicentre, randomised, double-blinded, parallel-group, placebo-controlled phase III trial |
| Study acronym | TRYMS |
| Study objectives | This trial aims to establish whether testosterone replacement therapy can improve body composition and quality of life in young hypogonadal male cancer survivors. |
| Ethics approval(s) | Derby 1 Research Ethics Committee, 08/09/2011, ref: 11/EM/0164 |
| Health condition(s) or problem(s) studied | Testicular cancer, lymphoma or leukaemia and low testosterone level |
| Intervention | 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 for all participants. |
| Intervention type | Other |
| Primary outcome measure | 1. Body composition, assessed after 26 weeks 2. Participant self-reported physical function scores, assessed after 26 weeks |
| Secondary outcome measures | 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 |
| Overall study start date | 01/07/2011 |
| Completion date | 31/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 268 |
| Total final enrolment | 136 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2011 |
| Date of final enrolment | 31/01/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leeds
Leeds
LS2 9JT
United Kingdom
LS2 9JT
United Kingdom
Sponsor information
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research Department
1st Floor
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom
"ROR" |
https://ror.org/018hjpz25 |
|---|
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (Reference A11891)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/11/2019 | 15/11/2019 | Yes | No |
Editorial Notes
15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
22/05/2017: No publications found, verifying study status with principal investigator.
03/10/2014: The overall trial end date was changed from 30/06/2014 to 31/01/2015.
