Testosterone replacement in young male cancer survivors

ISRCTN	ISRCTN70274195
DOI	https://doi.org/10.1186/ISRCTN70274195
Protocol serial number	STH15216
Sponsor	Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Funder	Cancer Research UK (CRUK) (UK) (Reference A11891)

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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-testosterone-replacement-in-young-men-who-have-had-cancer-treatment-tryms

Contact information

Ms Jayne Swain
Scientific

Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective multicentre randomised double-blinded parallel-group placebo-controlled phase III superiority clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Body composition, assessed after 26 weeks 2. Participant self-reported physical function scores, assessed after 26 weeks
Key secondary outcome measure(s)	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
Completion date	31/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	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

United Kingdom
England

Study participating centre

University of Leeds

Leeds
LS2 9JT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.