A study to develop a new way of assessing health and fitness in men with prostate cancer (True NTH Diet and Exercise Study – Redi)

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:

Other

This study aims to develop a way of assessing men that could help to provide them with a personalised diet and exercise plan following treatment for prostate cancer. It is recruiting men who have been diagnosed with prostate cancer in the last 3 years and who have finished their initial treatment (they may still be having hormone therapy).

Prostate cancer and its treatment can have a significant impact on a man’s life. For example, hormone therapy can lead to men gaining weight and losing muscle. This weight gain can increase the risk of other medical conditions such as diabetes and heart problems.

More about this trial

Research has shown that men with prostate cancer who are a healthy weight and do regular exercise can reduce their risk of dying from cancer. This can also lower the likelihood of other health problems, as well as improving general well being. But unfortunately many men recovering from treatment do not exercise enough and are overweight.

The study team intend to design a programme that can be used in community settings. These are places that men use and feel comfortable in, for example their local pharmacy. The researchers hope that this new programme (including assessment and individual advice about diet and exercise) will encourage men to change their lifestyle and improve their health.

In this part of the study, the researchers are looking at assessing men’s health and fitness. They will then develop a programme including the assessment tool and a diet and exercise plan. When the programme has been developed, the researchers will carry out another study to find out how useful it is and whether it improves men’s health and well being.

Who can enter

You may be able to join this study if you have been diagnosed with prostate cancer in the last 3 years, you have stage T1, T2, or T3 disease , your cancer is not showing any signs of growing and 1 or more of the following apply. You

  • Are having hormone therapy to treat your prostate cancer
  • Are ether overweight or underweight, this means that your body mass index (BMI) Open a glossary item shows that your are either below or above what is considered to be a healthy weight (the trial team can explain this to you in more detail)
  • Have high blood pressure Open a glossary item

You cannot join this study if any of these apply. You

  • Have had external radiotherapy to treat your prostate cancer in the last 3 months
  • Have had surgery or internal radiotherapy (brachytherapy) in the last 6 months
  • Have certain heart problems (the trial team can advise you are about this)
  • Already exercise quite regularly (for example you do about 2 ½ hours of moderate exercise or 1 ¼ hours of vigorous exercise every week)

Trial design

This study aims to recruit 92 men at 2 different hospitals.

First of all, the researchers will send you a questionnaire through the post which you fill in at home. This will ask you about your diet and how active you are. It will take about 20 minutes to fill in.

You then have your health assessment. Just before the assessment, you see a doctor who will examine you and ask you about your medical history and any medicines that you take. You have a heart trace (ECG Open a glossary item) and your blood pressure is measured.

The researcher will then explain the different tests that you are going to have. You have a blood test and your height, weight and waist are measured.

You have a test called a bioelectrical impedance test. This involves having electrode pads on your hands and feet while a machine calculates your body fat percentage.

Your muscle fitness and strength is measured with 3 short tests. Your grip strength is measured by asking you to grip tightly onto a handheld device. Your fitness is tested by asking you to move from sitting to standing and up and down a step over a certain amount of time. You also have various measurements taken while you are using an exercise bike.

After all the tests are finished, the researcher will explain your test results to you and you will be able to ask any questions. You have another health assessment 3 months later. They will also ask you to fill in the questionnaire again after 3 months.

Some of the men who have had a health assessment will be invited to take part in an interview with the researcher. This will take place at a later date. They will ask you about your experiences during the assessment and what you thought of this.

The results from the questionnaires, health assessments and interviews will be analysed. The study team will then design a simple health programme that can be used in a variety of community settings. It will include the assessment tool and a diet and exercise plan.

Hospital visits

Your doctor or clinical nurse specialist will invite you to join this study. If you agree, a researcher will then telephone you at home and ask you some questions to find out if you are eligible to take part.

Your health assessment takes place at hospital, or in university buildings close to hospital. This takes about 1 ½ hours.

If you take part in an interview, you have this at home at a time that suits you.

Side effects

You are closely monitored during your health assessment. It is unlikely that you will have any side effects. Some men may feel faint or lose balance or feel tired. The researcher will adjust your activity in the tests to try to prevent this from happening.

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

Professor Sara Faithfull

Supported by

NIHR Clinical Research Network: Cancer
Prostate Cancer UK
Royal Surrey County Hospital NHS Foundation Trust
The Newcastle upon Tyne Hospitals NHS Foundation Trust
University of Surrey

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12702

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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