A study using exercise to help with the side effects of prostate cancer treatment

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

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Phase 3

This study looks at the effect of resistance exercise in men after surgery to remove the prostate gland (radical prostatectomy).

Researchers want to find out if using body weight and resistance bands help men to have fewer side effects from prostate cancer treatment. They are comparing the health, strength and way the heart works (cardiovascular function) of men who follow a specific exercise program with those that continue with their usual exercise routine. 

More about this trial

Doctors usually treat prostate cancer with a combination of surgery to remove the prostate gland, radiotherapy Open a glossary itemand hormone therapy Open a glossary item. Men who have had prostate surgery often have side effects like urinary incontinence Open a glossary item, impotence Open a glossary item, pain, depression, tiredness and are physically less active.

As a result of being less active due to treatment, men tend to get muscle loss and gain extra body fat.

Previous research found that resistance exercise helps people to feel less tired and depressed. Researchers also found that resistance exercise, when compared with exercise like swimming or cycling which increases the heart and breathing rate (aerobic exercise), may have more health benefits and a greater improvement in the quality of life for older men.  

When resistance exercises are learnt under supervision, it might have long term improvements in health, compared to aerobic exercise. These benefits can continue if people have an exercise programme they can do at home.

The aim of this study is for researchers to learn more about the benefits of home-based resistance exercise on men who have had surgery for the treatment of prostate cancer. 

After this study, researchers want to do a second study. They want to find out what the health benefits of resistance exercise are in men who have had treatment with hormone therapy for prostate cancer. 

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can join the trial

You may be able to join this study if all of the following apply. You

  • Have been diagnosed with prostate cancer
  • Have had surgery to remove your prostate gland (a radical prostatectomy) 8-12 weeks before joining the study
  • Have had a cardio-pulmonary exercise test (CPET) for major surgery in the 4 months before joining the trial

Who can’t join the trial

You can’t join this study if any of these apply. You

  • Are taking part in another study that doesn’t allow you to take part in this study
  • Are having treatment for another cancer
  • Are having planned surgery within 3 months after being put into one of the randomly chosen study groups of this study
  • Are not able to do resistance exercise training because the clinical investigator of this study found that you are not well enough to do so 

Trial design

This is a phase 3 study. The researchers need 60 men to take part. 

The researchers completed the first two phases of the study. In phase 1 they collected information to help them understand the health problems and exercise needs of men after surgery to remove the prostate gland. 

In phase 2 they met with men who had prostate cancer treatment to help develop the exercise programme. They also asked health professionals their opinion on exercise as part of treatment for prostate cancer. 

This is a randomised study. This means that there are 2 different groups in the study. An independent person will put the men taking part into one or other group at random. Neither the doctor nor the men taking part in the study can choose which group they go into

There are 2 groups:

  • the intervention group: they continue with usual care and do a supervised resistance exercise programme 
  • the control group: they continue with usual care only

study diagram

Intervention group

In the intervention group, you do 3 sessions of resistance exercises each week for 24 weeks.

You follow a specific schedule:

  •  week 1 – you attend the hospital and have all 3 sessions under supervision
  • week 2 – you attend the hospital for 2 sessions under supervision and do the third session on your own at home
  • weeks 3-4 – you attend the hospital once a week for 1 session under supervision and you do 2 at home
  • weeks 5-12 – you do all sessions without supervision at home, but one of the researchers contact you weekly to hear how you are getting on
  • weeks 13-24 – you do all the sessions without supervision at home and have no contact with the researchers, but they want you to continue with the programme

Control group

You continue with your usual level of activities if you are in the control group.

Hospital visits

Both groups

Men in both groups attend the hospital for the following visits and tests:

Screening visit

You attend the hospital for a screening visit before the study starts. For some people the screening visit and the first testing visit will be combined. You will have the following tests as part of the screening:

  • blood pressure
  • heart rate
  • heart trace (ECG Open a glossary item)

Testing visit 1 (week 0)

You attend the hospital for tests.

The researcher:

  • discusses with you what happens in the session
  • tells you what they are asking you to do during  the study

You can ask questions during this session.

You have the following tests:

  • a 12-hour fasting blood test
  • flow-mediated dilation (FMD)
  • an arm and leg strength test
  • an exercise test on a treadmill (sub-maximal walking exercise)
  • body mass index Open a glossary item (BMI)
  • a skin folds and waist circumference measurement
  • blood pressure
  • heart rate

You fill out the following questionnaires:

  • 2 quality of life (QoL Open a glossary item) questionnaires
  • a Brief Fatigue Inventory questionnaire
  • a physical activity quesionnaire (Godin Leisure Time Exercise Questionnaire)

Men in both groups visit the hospital again during week 13 and 25 of the study. You have the same tests and fill out the same questionnaires as during testing visit 1.

Intervention group only 

Apart from attending testing visits 1-3, you will also be invited to visit the hospital for supervised exercise during:

  • week 1 for 3 sessions 
  • week 2 for 2 sessions
  • week 3 and 4 for 1 session each

Side effects

There are no side effects from this study. You might have some mild discomfort during the testing sessions. 

You might have some muscle soreness for a few days if you are in the intervention group. This is completely normal when starting a new exercise regime.

Tell the researcher immediately if you have any pain or discomfort during the tests or exercises.

Recruitment start:

Recruitment end:

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.

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

Chief Investigator

Prof John Saxton

Supported by

The Freeman Hospital
University of Northumbria at Newcastle upon Tyne
Tackle Prostate Cancer
The Urology Foundation

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14492

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

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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