Prevalence of complementary medicine use in a phase 1 clinical trials program

Abstract

BACKGROUND: A key end point of early cancer clinical trials is the assessment of toxicities and their possible associ- ation with new experimental drugs. Therefore, the concurrent use of complementary and alternative medicine (CAM) in patients with advanced malignancies seen in a dedicated phase 1 clinic was evaluated. METHODS: An investigator- designed survey was anonymously completed by patients seen in the phase 1 clinic. Pharmacologic CAM included any oral, topical, or intravenous agent, including vitamins, dietary supplements, and herbal products. Nonpharmaco- logic CAM included prayer, meditation, hypnosis, massage, and acupuncture. RESULTS: Of the 404 patients approached about completing the CAM survey, 394 (98%) agreed to respond, and 309 (78%) surveys were returned. Of those 309 patients, 162 (52%) used 1 or more CAM. Of the 162 CAM users, 77% utilized pharmacologic CAM, 71% used nonpharmacologic CAM, and 48% used both modalities. The most frequent CAM used were vitamins (70%), prayer (57%), and herbal products (26%). CAM utilization was not significantly associated with race, age, level of edu- cation, employment, or income level but was used more by women than men (P < .01). There was no statistically sig- nificant association between the use of CAM and quality of life as perceived by patients. Of the CAM users, 43% of patients had been using CAM for >5 years. Only 5% reported having side effects from using CAM, whereas 23% did not fully disclose their CAM use to their physicians. CONCLUSIONS: CAM usage is common in patients with advanced malignancies seen in a phase 1 clinic.