How should we take into consideration experimental data about the interaction of CAM and antitumoral medicacian therapeutics when planning an individual therapy or a study?

How should we take into consideration experimental data about the interaction of CAM and antitumoral medication therapeutics when planning an individual therapy or a study?

Decisions about therapy should be based on evidence derived from clinical studies preferentially from randomized blinded and controlled studies.

Unfortunately regarding CAM high-ranking studies are mostly missing.

As most of our patients use classical therapy and CAM in parallel we have to be very cautious about possible interactions.

As part of the German Cancer Organisation (DKG) AKKOM takes part in the development of guidelines.

In this process we are discussing whether we should take into consideration preclinical data for a substance that could be used as supportive agent (e.g. Ginseng against fatigue) if there are data revealing a negative potential of the substance.

These thoughts are in contrast to the usual process of guidelines in which preclinical data are regarded as data of insufficient evidence.

Yet I strongly recommend considering them because most CAM substances are tested as supportive therapy and most of the clinical studies on this field are not designed to tell us enough about possible negative impacts on therapy, long-term consequences and patient survival. Only in a minority of studies there are secondary endpoints like overall survived and mostly either the design of the study or the number of patient is insufficient to answer this question.

In the case of an individual therapy decision the same considerations should be made for the safety of our patients.

Whenever there are experimental data which show that the substance can diminish the effect of our chemo-, radio- or targeted therapy we have to be very careful to use it even if there is a high level of evidence for its usefulness as supportive agent.

In most clinical studies any use of CAM is prohibited but we know that the compliance of patients at this point is not good. So it could be an idea to explicitly allow for the use of certain CAM substances that have been checked for their usefulness and interactions.

AKKOM is in contact with study groups and the industry and first studies with a CAM substance as supportive agent in combination with new substances have been designed.

To my opinion these considerations should also be made concerning classical supportive therapy. If we look at the potential interactions of most of these substances and at the design of the studies in which they have been approved I think we must admit that we do not know whether there could be a negative impact on long-term outcome.

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