A trial looking at testosterone replacement in young men who have had cancer treatment (TRYMS)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Acute leukaemia

Bladder cancer

Blood cancers

Chronic leukaemia

Hodgkin lymphoma

Leukaemia

Lymphoma

Non-Hodgkin lymphoma

Testicular cancer

Status:

Closed

Phase:

Phase 4

This trial is looking at a gel that contains the male hormone testosterone Open a glossary item to see if it helps men who have low levels of testosterone after cancer treatment. The trial is supported by Cancer Research UK.

We know from research that men aged 25 to 50 who have had treatment for cancer may have lower levels of testosterone than other men. A low testosterone level may cause

An increase in body fat and weight gain
A reduced sex drive
A lower sense of general well being

Men who have very low levels of testosterone can have treatment to replace the hormone. But doctors are unsure of the best way to help men who have testosterone levels that are just a bit lower than normal. They call this a borderline low level.

The aim of this study is to see if a gel containing testosterone can help men with borderline low levels of testosterone following cancer treatment. The researchers want to see if it can help reduce body fat, and improve sex drive and general wellbeing.

Who can enter

You may be able to enter this trial if you

Are male and have been through puberty
Are between 25 and 50 years of age
Have had treatment with the aim of curing testicular cancer, lymphoma or leukaemia
Finished your cancer treatment at least 12 months ago
Have a borderline low level of testosterone (the trial team will do a blood test to check this)

As well as the above, if you've had a bone marrow transplant using cells from a donor, you must have finished steroids Open a glossary item at least a year ago. If you are taking hormone replacement drugs, you must have been on stable doses for the last 6 months.

You cannot enter this trial if you

Are very overweight (your body mass index is higher than 35)
Have had any other testosterone treatment in the last year (you can take part if you are having replacement of any other hormone, as long as you have been on a stable dose for at least 6 months)
Take steroids , or are likely to need to take them during the trial (you can ask your doctor about this)
Have had an allergic reaction to the testosterone gel being looked at in this trial (Tostran)
Have had primary liver cancer in the past, or a cancer such as prostate cancer or breast cancer that can be affected by hormones
Have high levels of calcium in your blood
Have an abnormal full blood count or PSA blood test
Have high blood pressure that cannot be controlled with medication
Have type 1 diabetes - if you have type 2 diabetes, you may be able to take part if you have been on stable treatment for at least 6 months
Have moderate or severe heart failure
Have kidney problems (including nephrotic syndrome)
Have pauses in your breathing when you are asleep (sleep apnoea)
Have another medical condition or take other medication that can affect your body fat
Have a condition called chronic graft versus host disease following a bone marrow transplant
Have certain types of liver disease or any other medical condition that could affect the results of the trial
Are intending to try to conceive within the next 12 months (unless intending to use previously banked sperm)

Trial design

The trial will recruit up to 268 men. It is a randomised trial. The men taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.

Men in one group use a gel called Tostran that contains testosterone. Men in the other group use a gel that looks the same but does not contain any testosterone (a placebo Open a glossary item ).

You use the gel everyday for 6 months in the trial. You spread it on your tummy or the inside of your thighs. The trial team will tell you exactly how and when to use the gel. They will also give you a leaflet to take home.

The researchers will ask you to complete some questionnaires before you start treatment, after 3 and 6 months of treatment. The questionnaires will ask about your health and general wellbeing, your self-esteem and your sex life. Some of these questions are very personal and explicit. If there are any questions that you don’t want to answer, or are not able to answer, you can miss them out.

All the information you give is confidential Open a glossary item . You put the completed questionnaires into an envelope that is sealed and sent to the researchers at the University of Leeds. Your answers will only by seen by people who don’t know your name.

Hospital visits

You see the trial doctors and have some tests before you start treatment. This includes blood tests and a whole body scan using X-rays (a DXA scan).

You have another blood test after 2 weeks. Depending on the results of this test, the trial team may tell you to change the amount of gel you use.

You have hospital visits after 3 and 6 months of treatment. At these visits, you have blood tests. A member of the trial team will take a measurement around your waist as well as weighing you and checking your blood pressure. At the last visit you will also have another body scan.

Side effects

A common side effect of the gel is skin irritation such as a rash, dry skin, itching or redness in the areas where you have been applying the gel.

Other less common side effects of Tostran include

An increase in your number of red blood cells
Increased hair growth
Raised blood pressure
A decrease in the size of your testicles
Enlargement of your breast tissue and swelling of other soft tissue in your body
An increase in the size of your prostate gland
Pauses in your breathing when you are asleep (sleep apnoea)

You have blood tests during the trial and if your doctor thinks that you have any significant side effects, they can take you off the study.

Recruitment start:

30/05/2012

Recruitment end:

31/01/2015

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Richard Ross

Supported by

Cancer Research UK
Clinical Trials Research Unit (CTRU)
Experimental Cancer Medicine Centre (ECMC)
University of Leeds
NIHR Clinical Research Network: Cancer
ProStrakan
Sheffield Hospitals Charity
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield