Condition category
Cancer
Date applied
04/02/2011
Date assigned
19/05/2011
Last edited
03/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Jayne Swain

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STH15216

Study information

Scientific title

Testosterone Replacement in Young Male cancer Survivors: a prospective, multicentre, randomised, double-blinded, parallel-group, placebo-controlled phase III trial

Acronym

TRYMS

Study hypothesis

This trial aims to establish whether testosterone replacement therapy can improve body composition and quality of life in young hypogonadal male cancer survivors.

On 03/10/2014 the anticipated end date was changed from 30/06/2014 to 31/01/2015 .

Ethics approval

Derby 1 Research Ethics Committee, 08/09/2011, ref: 11/EM/0164

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

1. To assess the effect of 26 weeks of treatment with testosterone gel on body composition in hypogonadal cancer survivors
2. To assess the effect of 26 weeks of treatment with testosterone gel on participant self-reported physical function scores in hypogonadal cancer survivors

Secondary outcome measures

1. To assess the effect of 26 weeks of treatment with testosterone gel on BMI, blood insulin, glucose, lipid levels and bone density in hypogonadal cancer survivors
2. To assess the effect of 26 weeks of treatment with testosterone gel on participant self-reported quality of life, fatigue, self-esteem and sexual function scores in hypogonadal cancer survivors
3. To assess the effect of 39 weeks of treatment with testosterone gel on participant self-reported quality of life, fatigue, self-esteem and sexual function scores in hypogonadal cancer survivors

Overall trial start date

01/07/2011

Overall trial end date

31/01/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

268

Participant 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

Recruitment start date

01/07/2011

Recruitment end date

31/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Research Unit
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

Research Department
1st Floor
11 Broomfield Road
Sheffield
S10 2SE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (Reference A11891)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes