Research into therapies

Monday 2 February, 2009

Reviewed: A/P Michael Jefford,Consultant Medical Oncologist, Peter Mac; Dr Raymond Snyder, Director of Oncology, St Vincent's Hospital; Beth Wilson, Health Services Commissioner, Victoria; Dr Amanda Hordern, Director, Cancer Information and Support Service. Developed with funding from the Victorian Department of Human Services.

On this page: About clinical trials ι Research trends into therapies ι Finding out about clinical trials

Like all other treatments for cancer, it is important to research complementary and alternative cancer therapies.

People need to know about their possible side effects, effectiveness and how they may improve quality of life for the person with cancer. Without science-based research, we cannot know how safe or effective any type of treatment is.

There is no scientific reason why many of these therapies cannot be tested. Anecdotal evidence is not enough to prove a treatment works. It may be coincidental, or due to conventional cancer treatments that they also had. (See ‘Why do alternative therapies work for some people?')

For ethical and safety reasons, all drugs and techniques used in conventional cancer treatment must be tested in clinical trials. If researchers decide to study a medicine, vitamin, herb or other substance, this is first done in the laboratory. If anything shows signs of being able to help treat, prevent or cure cancer, it is then tested in people in clinical trials. Some therapies, such as massage, chiropractics and acupuncture, can't be tested in a laboratory, but these therapies still ought to be tested in properly conducted clinical trials to see that they are safe and will actually benefit people.

Cancer Council Australia ‘recommends that the National Health and Medical Research Council funds scientific studies to examine the safety and effectiveness of promising and commonly used complementary and alternative cancer medicines, so that people with cancer and health care providers can differentiate between those that are not beneficial or are dangerous and those that are helpful'.

About clinical trials

There are four phases of clinical trials.

Phase 1 trials only involve a few people (maybe five to 20). They may involve people with many different types of cancer. At this stage patients are given a very small dose of the substance being tested. As people tolerate it the amount is slowly increased and side effects are very closely monitored. The aim of this type of study is to find a safe dose as well as possible side effects.

Phase 2 trials test how well the treatment works with a specific type of cancer. They also involve small numbers of patients. The aim at this level is to see whether the treatment has a benefit for people with cancer.

Phase 3 trials start once the treatment has been shown to be safe and effective. They then compare the new treatment with a standard treatment to see if it works as well or better. This usually involves hundreds or thousands of people from one country or around the world. Phase 3 trials are usually randomised. This means that people are chosen by chance to go in a certain group. Neither the patient nor their doctor knows which treatment the patient is having (this is called ‘blind' study). This is the best way to avoid bias results from a trial.

Trials may not be just about whether or not the treatment will shrink the cancer but also whether or not the treatment makes people feel better. ‘Quality of life' studies are often done alongside phase 3 trials. They look at how the treatment or illness affects people and all parts of their lives - work, home life, emotions, relationships and health.

Phase 4 trials are carried out after a drug has been licensed. They collect further information about side effects, safety and the long-term risks and benefits of a drug.

Researchers can also look at the results from several or many similar trials together to give them a better idea about a treatment. This is called a ‘systematic review' or a ‘meta analysis'.

Research trends into therapies

Results from well-designed trials would give us answers about the effectiveness and safety of certain complementary therapies and alternative therapies. It is often difficult to get funding in this area:

  • Trial designs for this type of research are often difficult to do.
  • Many complementary therapists don't have experience in designing clinical trials.
  • It can be difficult to find the time and resources for cancer specialists and complementary therapists to work together on a research study.

However, there have been some promising developments. The European Research Initiative on Complementary and Alternative Medicine (EURICAM) has been set up. This aims to encourage European governments to spend more on researching complementary and alternative therapies.

In the US and UK research in this area has been increasing for the past few years. In the US research has focused on the use of herbs, vitamins and other dietary supplements. In the UK the ‘hands on' or ‘touch' therapies' such as massage and reflexology have been the area of interest, along with mind-body therapies (visualisation, hypnosis and yoga). There has also been a significant amount of research into how acupuncture can help people with cancer.

In Australia there are moves to try to improve the situation. For example:

  • In 2007 the National Health Medical Research Council (NHMRC) made a special call for researchers to apply for funding to increase knowledge in the area of complementary and alternative medicine.
  • A project by the National Breast and Ovarian Cancer Centre and Cancer Council Victoria is aiming to help health professionals effectively discuss complementary and alternative medicine with cancer patients, their families and friends.
  • The Society of Integrative Oncology was established in 2003. This is a non-profit organisation for health professionals who are studying and using complementary therapies for people with cancer. It is encouraging awareness and opportunities for international research and holds yearly conferences to discuss trial results and ideas for new areas of research.

Finding out about clinical trials research

Your cancer specialist can advise you about trials that may already have been done as well as let you know if there are any trials currently in progress. It's good to ask - your interest will help health professionals become more aware that people do want more research into the use of complementary and alternative cancer therapies.

See ‘Useful websites' for more about research and clinical trials.

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