Background: Every seventh to eighth woman is diagnosed with breast cancer in her life. Next to surgery and radiotherapy most of them receive (neo)adjuvant chemotherapy, which comes along with adverse effects. Complementary and alternative medicine (CAM) like Reiki can reduce these effects. Reiki is a Far Eastern method that promotes healing on a physical, mental and emotional level and activates self-healing powers. REASSURE examines the effects of Reiki on quality of life and taxane-induced polyneuropathy during chemotherapy.

Methods: REASSURE is a prospective, randomized, controlled, two-armed clinical trial, in which patients with breast cancer receive chemotherapy and Reiki (18 times) or chemotherapy and sport (18 times). During chemotherapy and before and after every Reiki- or sport-session the patients fill out standardized questionnaires (e.g. FACT/GOG-NTX Version 4). Primary endpoint is the comparison of quality of life at the end of chemotherapy between Reiki and sport based on the FACT/GOG-NTX score by T-Test. Secondary endpoint is the comparison of the taxane-induced polyneuropathy at the end of chemotherapy between the two groups. Also short-term effects before and after the Reiki- and sport-session will be examined. A power of 1-β = 0.8, a bilateral probability of error of α = 0.05, a minimum relevant difference deltaθ = 4 and a pooled standard deviation of 11 for the two-sided T-Test result in case numbers of 2 x 120 = 240 patients.

Conclusion: REASSURE is the most comprehensive prospective study to the effects and the feasibility of Reiki on breast cancer patients during chemotherapy so far.

Since July 2015, 138 patients have been enrolled at three different centers. Currently 63 patients in total (39 patients of the Reiki-group and 24 patients of the sport-group) have completed the study. 24 Reiki-patients and 36 sport-patients are counted as dropouts because of reasons like incomplete data records, discontinuation of chemotherapy, not enough time or energy for Reiki- or sport-sessions or other reasons.

Sponsor: This is a collaborative study of the Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technische Universität München (TUM), Munich, Germany, Rotkreuzklinikum München, Frauenklinik, Munich, Germany, Department of Gynaecology, Städtisches Klinikum München Harlaching, Munich, Germany and the ProReiki – der Berufsverband e.V., Berlin, Germany.

Contact Information: For further information contact Sophie Katzendobler via sophie.katzendobler@gmail.com or the leading physician Dr. Johannes Ettl via johannes.ettl@tum.de.

Citation Format: Katzendobler S, Haunreiter L, Zander L, Schmidt R, Andrulat A, Münch K, Hanusch C, Napieralski R, Petri I, Ettl J. REASSURE- Effects of Reiki as supportive treatment during chemotherapy of breast cancer: A prospective, randomized, controlled clinical trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT1-05-05.