Impact of Open Dialogue about Complementary Alternative Medicine-A Phase II Randomized Controlled Trial.

Complementary alternative medicine (CAM) may reduce the symptom burden of side effects to antineoplastic treatment but also cause new side effects and non-adherence to conventional treatment. The aim of this RCT was to investigate the impact of open dialogue about complementary alternative medicine (OD-CAM) on cancer patients' safety, health and quality of life (QoL). Patients undergoing antineoplastic treatment were randomly assigned to standard care (SC) plus OD-CAM or SC alone. The primary endpoint was frequency of grade 3-4 adverse events (AE) eight weeks after enrollment. Secondary endpoints were frequency of grade 1-4 AE, QoL, psychological distress, perceived information, attitude towards and use of CAM 12 and 24 weeks after enrollment. Survival was analyzed post hoc. Fifty-seven patients were randomized to the OD-CAM group and fifty-five to the SC group. No significant difference in frequency of grade 3-4 AEs was shown. The same applied to grade 1-4 AEs and QoL, psychological distress and perceived information. A tendency towards better QoL, improved survival and a lower level of anxiety was found in the OD-CAM group. OD-CAM is not superior to SC in reducing the frequency of AEs in patients undergoing antineoplastic treatment. OD-CAM does not compromise patient safety; it may reduce psychological stress and improve QoL and overall survival.