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Clinical Trials: Common Questions - By Louise Gilham (Mesothelioma UK CNS)

As a Mesothelioma UK Regional Nurse Specialist, I am often asked about clinical trials. Here are just a few.

What is a clinical trial? Cancer trials are carried out to try to find new and better treatments for cancer.

Can anyone go onto a clinical trial? Unfortunately not - due to inclusion and exclusion criteria. However we try to recruit as many people as possible.

Is it only drugs that are used in clinical trials? Other than drugs, trials look at treatments such as surgery and radiotherapy. Others look at lifestyle, intervention of support and the way in which people are cared for.

I’ve heard / read that Clinical trials have different stages. Clinical trials are divided into different stages, called phases. Phase 0 - Aim to find out if a drug behaves in the way researchers expect it to from laboratory studies

Phase I - Trials are usually small and recruit only a few patients. The trial may be open to people with any type of cancer Phase II - Trials for people who have the same type of cancer. Side effects are looked at, how to manage them and also the best dose. Phase III - Trials compare new treatments with standard treatment. Standard treatments are those which are the best currently available. These trials involve more people and will be conducted in many hospitals and may be multi-national. Most phase III trials are randomised. Phase IV - Trials are done after a drug has been proven to work and has been granted a license. They aim to find out more about side effects and the safety of the drug. They show the long term effects and benefits of the drug.

What is a placebo & will I know if I’m having one? Placebos are often used in clinical trials as an inactive control so that researchers can better evaluate the true overall effect of the treatment under study without bias. Participants may not know if they are being given a placebo – this is known as “blinding”. However should the mesothelioma be progressing on the clinical trial and / or you are not tolerating treatment, your oncologist will discuss this with you and may considering other treatments. How am I randomised? This is done by computer selection.

Can I withdraw from a trial? You can withdraw from a trial at any point and don’t have to give a reason.

What are the possible benefits? You may have a new treatment that is only available in a clinical trial. You may have more check-ups, tests and scans than usual, which you may find reassuring. You will be helping to improve cancer treatments for future patients.

What are the possible drawbacks? You may have to do some trial paperwork. You may have unexpected side effects from the new treatment. You may have to make more trips to the hospital and trials may not be local. Travel bursaries may be available to help with the cost of this so speak with your nurse specialist.

Clinical Trials open to recruitment in Kent (More trials available within the UK) BEST: Standard Chemotherapy plus Atezolizumab (Immunotherapy) and bevacizumab (targeted therapy) versus Standard chemotherapy and bevacizumab. NEMO: Nintedanib - Targeted cancer drug CONFIRM: Nivolumab (Immunotherapy) versus placebo SYSTEMS 2: Radiotherapy MARS 2: Chemotherapy plus or minus surgery

There are also other studies available which you may want to participate in. MIMES: Interviews to explore the experiences of British Armed Forces personal / veterans with mesothelioma and their family members. MAGS: Healthcare Workers whom have developed mesothelioma. Interviews for both clinical staff, such as doctors and nurses, and non-clinical staff, such as medical secretaries, cleaners, porters and maintenance staff.

Whenever you meet with your oncologist or Mesothelioma / Lung Nurse Specialist – always ask about clinical trials. Mesotheliomas UK are available to advise, provide information about clinical trials and any other mesothelioma information on: 0800 1692409 or www.mesothelioma.uk.com

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