A study looking at the structure of the body and how it affects treatment side effects (CANDO-3)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at the amount of muscle and fat in the body and how it might affect the side effects of chemotherapy.
It is open to women with 
that has grown into the breast tissue ().
More about this trial
Chemotherapy is one of the main treatments for breast cancer. To work out how much chemotherapy you have doctors take your height and weight.
However the structure of everyone’s body is different and not everybody has the same amounts of muscle and fat. Having less muscle, but with more fat, has been linked to being less able to tolerate chemotherapy. This could make a difference to how bad the side effects of chemotherapy might be.
Using a machine that is like advanced bathroom scales the team can now assess the amount of muscle and fat in your body.
In this study the team use the machine before each of your chemotherapy treatments.
They will also ask you about any side effects that you might have had from the previous treatment.
The main aim of the study is to find out whether the differences in the amount of muscle and fat in the body can affect how bad chemotherapy side effects might be.
Please note you might not benefit directly from taking part in this study but the information gained could help people in the future who are having chemotherapy.
Who can enter
The following bullet points are a summary of 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 take part
You may be able to join this study if all of the following apply. You are a woman and:
- you have early invasive breast cancer (stage 1 to stage 3)
- the
grade of the cancer is known. And whether the cancer is ER positive or negative and if it is HER2 positive or negative. Your doctor will know about these. - the clinical details such as size of tumour and whether the
lymph nodes are affected are available. Your doctor will know if these are available. - you are to have chemotherapy that reaches the whole body (systemic chemotherapy)
- your chemotherapy contains an
anthracycline drug or a taxane drug. Your doctor will know this. - you are to have a
course of treatment that is more than 4 cycles of treatment and each cycle of treatment is 21 days. Ask your doctor about this. - you are able to write in English
- you are at least 18 years old and younger than 80 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have cancer that has spread to another part of the body
- have had another
invasive cancer within the past 5 years apart from non melanoma skin cancer - have had
systemic treatment for cancer in the past 10 years. This is apart from hormone treatment that you have started since this current diagnosis of breast cancer. - are only having 1 type of chemotherapy drug
- have a condition that affects how much water is in your body or that causes swelling
- have a muscle condition that might affect the amount of muscle in the body such as muscular dystrophy
- have any other medical condition that could affect you taking part
- have a pacemaker
- are pregnant
Trial design
The study team need 300 women to take part.
Taking part does not affect your chemotherapy treatment at all.
You see a member of the study team before each . They take measurements such as your weight and grip strength. You also stand on a machine that takes more detailed measurements of the structure of your body.
This is a Seca body analysis machine. It is like a big digital set of weighing scales with hand grips on the side to hold on to. You take off your shoes and socks to stand on the machine. You need to stay still for 75 seconds while it takes the measurements. The team member will tell what you need to do and how.
Participant on the study measuring machine
The team ask your doctor at the hospital a few questions about your treatment. They also look at your medical records. They might also ask to look at the results of any you might have as part of your treatment.
Questionnaires
You fill in some questionnaires before you start your treatment then:
- half way through your course of treatment
- at the end of treatment
- 3 months after you finish treatment
The questions ask about your lifestyle and general health. The research team will also ask about any side effects that you might have had. This takes about 20 minutes to do.
Hospital visits
The team will try their best to see you only when you are coming to the Hospital to see your cancer doctors and nurses or to have your treatment.
The research study visits before each treatment take about 20 minutes.
Side effects
There are no side effects from taking part in the study.
Each type of chemotherapy treatment has its own side effects. Your doctor will talk to you about the possible side effects of your treatment.
We have information about general side effects of chemotherapy.
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.
Chief Investigator
Professor Ramsey Cutress
Supported by
University of Southampton
University Hospital NHS Foundation Trust
World Cancer Research Fund (Funder)
Clinical Informatics Research Unit
Southampton Clinical Trials Unit
Southampton Cancer Research UK Clinical Centre
Association of Breast Surgery
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
