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Use of CAM in Phase I Clinical Trials

The Use of Complementary and Alternative Medicine (CAM)therapies and decision making in cancer patients participating in Phase I clinical trials

JD Winegarden, F Hlublocky, CK Daugherty

University of Chicago Medical Center, Chicago, IL

The described incidence of use of CAM in patients is increasing, yet it is unknown what proportion of patients participating in clinical trials take them.

Within Phase I trials, given the potential for incorrect assumptions about toxicity of an agent as a result of drug-alternative therapy interaction, nowhere may it be more important to accurately assess the usage of alternative therapies.

We conducted a survey interview study in order to describe the incidence of usage of CAM in phase I trials. Of the 212 subjects interviewed (95% interview response rate), 34% admitted to taking alternative therapies and an additional 30% admitted to having at least considered the possibility of taking them.

Median age of those admitting to taking alternative therapies was 54.5 years, compared to 62 years for those not taking alternative therapies (range 22-82) (p<0.55).

There was no significant difference detected in usage based on gender or race. While not statistically signficant, there was a trend for the very educated and the very uneducated to use CAM less than others.

CAM therapies listed were shark cartilage, Chinese herbs/teas, high-dose vitamins, acupuncture, meditation, and general dietary adjustments.

Using a validated instrument, there was a trend for individuals who preferred either to defer decision-making to their M.D. or to be the sole decison maker to be less likely to use CAM therapies than those who preferred to share decision-making (15% vs. 36%) (p=0.08).

The incidence use rate of CAM therapies among cancer patients in phase I trials is significant and associated with age and preferences for decision making participation.

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